What happens when an IAB catheter fails?

When an intra-aortic balloon (IAB) catheter fails, it may not inflate or deflate properly, inflate at the wrong time, or stop working altogether. Because the device is intended to support a failing heart, any malfunction can reduce blood flow to vital organs, worsen cardiogenic shock, trigger dangerous blood pressure changes, or contribute to organ failure or cardiac arrest. In critically ill patients, even brief interruptions in support can be life-threatening. An IAB catheter can sometimes fail without doctors realizing it right away, particularly if the device provides inaccurate pressure readings or appears functional despite internal defects.

How do I know if an IAB catheter caused my injury or my loved one’s death?

Determining whether an IAB catheter contributed to injury or death often requires reviewing medical records, device data, and the timeline of events before and after the catheter was used. Sudden drops in blood pressure, unexplained organ failure, or rapid deterioration following placement or removal may raise concerns. These connections are not always obvious to families, and individual hospitals’ notification practices regarding the use of recalled devices can vary, especially if the recall occurs later. An experienced medical device attorney can investigate whether device failure played a role in causing complications, injury, or patient death.

Can I file a lawsuit if the patient was already critically ill?

Yes. Patients who receive IAB catheters are often critically ill by definition, but that does not excuse a manufacturer from responsibility if a defective device worsened the patient’s condition or reduced their chance of survival. The legal question is not whether the patient was sick, but whether the catheter failed to perform as intended and caused additional harm. Even when a patient faces serious underlying heart problems, a defective medical device may still be a substantial contributing factor to injury or death. If so, this fact can form the basis for a valid product liability claim.

Can family members file a lawsuit if a patient died from an IAB catheter failure?

Yes. If an IAB catheter malfunction contributed to a patient’s death, surviving family members may be able to file a wrongful death lawsuit. These claims are typically brought by a spouse, children, or the personal representative of the estate. Through legal action, you may be able to seek compensation for medical expenses, funeral costs, lost financial support, and loss of companionship. Families do not need proof of medical device defects at the outset of the case, only a reasonable concern that device failure played a role. A lawyer can review records, consult experts, and determine whether the manufacturer or others may be legally responsible.

Who can be held responsible for injuries caused by a defective IAB catheter?

Multiple parties may be held liable for injuries caused by a defective IAB catheter. This can include the device manufacturer, companies involved in design or production, and, in some cases, distributors or suppliers. Liability may be based on design defects, manufacturing defects, or failure to warn about known risks. While hospitals and physicians are not usually responsible for product defects, they may be involved if errors occurred in handling or response. A thorough investigation is often required to identify all responsible parties and pursue appropriate legal claims.

How long do I have to file an IAB catheter lawsuit?

The time limit to file an IAB catheter lawsuit, known as the statute of limitations, varies by state and by the type of claim, such as personal injury or wrongful death. In many cases, the clock starts when the injury occurred or when it was reasonably discovered, not necessarily when the device was used. Because medical device injuries and recalls are often identified later, delays can affect your rights. Speaking with an attorney as soon as possible helps ensure deadlines are met and important evidence is preserved.

Anapol Weiss/

Philadelphia Mass Tort Lawyers/

Teleflex Arrow Catheter Lawsuit Attorneys

Arrow IAB Catheter Lawsuit Lawyers

Teleflex Arrow FiberOptix and UltraFlex IAB Catheter Lawsuit Attorneys

When the heart fails to pump blood sufficiently throughout the body, the consequences can be life-threatening. Interventions using intra-aortic balloon (IAB) catheters can provide much-needed support for patients facing heart failure, undergoing cardiac surgery, or otherwise in need of assistance to decrease the heart’s workload and improve circulation. Any failures of these devices can have catastrophic health outcomes, especially since they are used primarily to support patients who are already critically ill. For injured patients and their families, the Arrow IAB catheter lawsuit lawyers at Anapol Weiss are here to hold medical technology companies like Teleflex accountable.

Leading this practice area at Anapol Weiss are attorneys with extensive experience handling both individual and mass tort matters involving complex medical device failures: Kila Baldwin, shareholder; Catelyn McDonough, partner; Dominique Montoya, associate; and Tyler Davis, associate.

Baldwin’s recoveries on behalf of her clients amount to hundreds of millions of dollars. Among her high-profile victories are verdicts of $80 million, $57.1 million, and $41 million in transvaginal mesh cases against manufacturer Johnson & Johnson; a $20.7 million verdict against Honda in collaboration with Anapol Weiss shareholder Larry Coben; and, as co-counsel, a $35 million recovery in the Bridgeport fire case on behalf of more than 100 individuals and businesses.

McDonough has helped obtain millions of dollars for mesothelioma patients and their families, as well as a $1 billion verdict against Johnson & Johnson and its DePuy Orthopaedics Inc. unit for design and manufacturing defects in Pinnacle metal-on-metal hip implants. She was part of the trial team for the fourth bellwether trial against J&J and DePuy, resulting in a $247 million plaintiff verdict, and has worked on several multidistrict litigations (MDLs) involving pharmaceutical and medical device liability.

Montoya has first-chaired multiple jury and bench trials that resulted in favorable verdicts in cases involving personal injury, medical malpractice, and dangerous products. She has cultivated extensive civil litigation experience working at some of the most prominent firms in Philadelphia. Davis devotes his practice to complex civil litigation matters on behalf of individuals who have suffered catastrophic personal injuries, including those harmed by transvaginal mesh injuries and other types of dangerous product injuries.

Our firm is actively investigating potential cases against Teleflex arising from injuries caused by the company’s Arrow FiberOptix and UltraFlex IAB catheters, which have been recalled due to safety concerns. By filing a claim against this medical device company, you may be able to pursue compensation to help your family move forward. For a free consultation with a compassionate legal advocate at a longstanding, nationally recognized injury firm, contact us today.

Who Can File a Teleflex Arrow IAB Catheter Lawsuit?

At Anapol Weiss, our Teleflex Arrow FiberOptix and UltraFlex IAB catheter lawsuit attorneys are committed to pursuing legal recourse for every patient and family harmed by the negligence of medical device manufacturers. We are actively investigating potential cases on behalf of clients who:

Received circulatory support during surgery, heart failure, or other appropriate circumstances using the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit or Arrow UltraFlex Intra-Aortic Balloon Catheter Kits, and
Suffered injuries such as blood loss, artery perforation, obstruction of blood flow to the heart, or death.

For patients and families, the type of IAB catheter used during medical intervention often isn’t common knowledge. A thorough review of medical records can provide answers about whether a Teleflex Arrow catheter that is now subject to a recall was used and whether eligibility for a claim exists.

We invite patients who suffered these and other complications while being treated for heart conditions or during surgery to reach out for a free, no-obligation case evaluation. You have nothing to lose if it turns out that you aren’t eligible to file a Teleflex Arrow IAB catheter lawsuit. If you do have grounds for a claim, depending on the facts, you could seek compensation for all of the harm caused by a defective medical device.

How Defective Teleflex IAB Catheters Put Heart Surgery Patients at Risk

Intra-aortic balloon catheters have the potential to save lives, but timing, proper placement, and reliable function are critical. These medical devices are used in dire circumstances when the heart is unable to pump blood sufficiently. Defects and failures can not only prevent the catheters from serving their intended purpose but may even put already vulnerable patients at greater risk.

The Critical Purpose IAB Catheters Serve

IAB catheters, like Teleflex’s Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, play an important part in keeping patients safe during surgery and in treating patients suffering from heart-related medical conditions.

Intra-aortic balloon (IAB) catheters are typically used when a person’s heart is struggling to pump enough blood. This can happen for numerous reasons, including:

Cardiogenic shock
Severe heart failure
Complications following a heart attack
High-risk cardiac surgery or catheterization procedures

Inserting an IAB catheter can provide temporary circulatory support, improve coronary perfusion, and reduce the heart’s workload. In some emergencies, that support can help maintain organ perfusion while clinicians treat the underlying condition, potentially preserving organ function and even saving lives. However, a manufacturing issue in certain Arrow FiberOptix and UltraFlex IAB catheter produced by Teleflex can prevent the device from working as intended, creating a risk of serious injury or death, according to U.S. Food & Drug Administration (FDA) recall communications.

How IAB Catheters Are Intended to Work

Once the IAB catheter has been inserted into the body (usually through the femoral artery in the groin) and positioned properly in the descending thoracic aorta, the body’s main artery, the balloon inflates during heart relaxation to push blood back toward the heart. The increased pressure helps deliver more oxygen-rich blood to the coronary arteries, providing oxygen to the heart muscle. During heart contractions, the balloon rapidly deflates, which creates a temporary vacuum effect in the aorta and allows the heart to pump blood with less resistance.

IAB therapy relies on precise, reliable inflation and deflation synchronized with each heartbeat. Any errors can have devastating results, including:

Reducing blood flow instead of improving it
Increasing stress on an already failing heart
Leading to serious complications or death

Some of the most common causes of these avoidable complications include the balloon:

Failing to inflate fully
Inflating at the wrong time
Deflating too slowly
Failing to completely deflate

Both the FiberOptix and UltraFlex IAB catheters that are part of the Teleflex Arrow line of medical devices are made to work differently.

Arrow FiberOptix catheters use a fiber-optic pressure sensor designed to provide real-time arterial pressure data without needing external fluid-filled lines.
Arrow UltraFlex catheters are designed to be more flexible, theoretically reducing trauma to blood vessels during placement and use.

Any defect in balloon performance, fiber-optic pressure sensing, or catheter integrity can have catastrophic consequences.

Teleflex Intra-Aortic Balloon (IAB) Catheter Kit Recalls

According to the FDA, medical device manufacturer Teleflex has recalled 16,959 Arrow FiberOptix and UltraFlex IAB catheter kits in the United States for manufacturing defects. The FDA categorizes this recall as a Class I, the most serious type of recall, which indicates that the use of these devices may cause serious injuries or death.

The recalled catheter kits include all kits distributed between May 7, 2022, and April 8, 2024, with the following product codes:

IAB-05830-LWS
IAB-05830-U
IAB-05840-LWS
IAB-05840-U
IAB-05850-LWS
IAB-06830-U
IAB-06840-U
IAB-06850-U

The reason for the recall, as explained by the FDA, is a manufacturing issue that can result in overtwisting of the balloon. In affected devices, this overtwisting can prevent full inflation of the balloon, leading to blood backing up into the device’s tubing, helium leaks, damage to the catheter, or insertion difficulty.

In patients, the FDA reported, these device problems may cause serious injuries such as:

Blood loss
Perforation (tearing) of the artery
Unstable blood pressure (also known as hemodynamic instability)
Obstruction of blood flow to the heart (myocardial ischemia)
Death

The FDA has already reported 322 complaints, including reports of 31 injuries and three deaths that are “potentially” related to this manufacturing issue in Teleflex Arrow FiberOptix and UltraFlex IAB catheter kits.

Filing a Defective Medical Device Injury Claim Against Teleflex

Injured patients and grieving families can hold Teleflex accountable for harm linked to defective IAB catheters. The dedicated team of Teleflex Arrow FiberOptix and UltraFlex IAB catheter lawsuit attorneys at Anapol Weiss is currently investigating potential cases. We are here to help your family get justice, answers, and the potential compensation you deserve.

Through civil legal action, we’re prepared to hold Teleflex and any other relevant defendants responsible for patient harm. We can demand answers through discovery, establish liability for manufacturing issues that prevent IAB catheters from working properly, and pursue a financial recovery that addresses your economic and non-economic losses as fully as possible. Generally, in medical device lawsuits, we may be able to seek compensation for damages such as:

Additional medical care, including extended hospital stays, further surgeries and procedures, and care required because of injuries resulting from relevant complications
Wage loss if the harm or any additional medical interventions needed impact your ability to work
Pain and suffering and other non-economic damages, which address the physical discomfort, emotional anguish, stress, and fear resulting from your injuries
Wrongful death damages for the bereaved families of patients who sustained fatal harm attributed to a medical device failure

Our Arrow IAB catheter lawsuit lawyers have a long history of standing up to medical device manufacturers and other major corporations. We know how important it is to hold these companies accountable, and we don’t back down.

How the Teleflex Arrow FiberOptix and UltraFlex IAB Catheter Lawsuit Attorneys at Anapol Weiss Can Help

To put your claim against a medical device manufacturer like Teleflex on the strongest foundation possible, you need a team of Arrow IAB catheter lawsuit lawyers with the knowledge and resources to take on complex product liability claims. At Anapol Weiss, we understand not only the challenging legal issues that can arise in these cases but also the highly technical nature of cutting-edge medical devices. We use these capabilities to your advantage.

Our clients count on us to:

Diligently investigate claims and analyze medical records, often in consultation with leading experts
Develop sound theories of liability and present compelling arguments for fair potential compensation
Represent their interests both inside and outside the courtroom
Tirelessly champion their cause, not just handle their case
Pursue the maximum potential compensation available under the circumstances so that the outcome of taking legal action makes the client as whole as possible

From your very first meeting with our team to the final resolution of your case, we’re here to stand by your side and advocate against powerful opponents. The legal process can be intimidating, but you won’t have to face a single form, hearing, or decision alone.

Why Choose Anapol Weiss as Your Arrow IAB Catheter Lawsuit Lawyers?

Your choice of legal representation matters, particularly when you’re taking on a global medical technology company like Teleflex. For Arrow IAB catheter lawsuit lawyers who are known for leading the legal landscape, securing high-value recoveries, and putting clients’ best interests first, Anapol Weiss is the clear choice.

Nationally-Recognized Leadership in Injury Litigation

Our team of dozens of nationally recognized litigation attorneys does more than practice law. We lead the legal process, shaping the future of personal injury and product liability law through our record of setting new precedents. We have successfully litigated thousands of cases in state and federal courts, and our lawyers have taken on significant leadership roles in multidistrict litigations.

A Reputation for Winning Big in Individual and Mass Tort Cases

With mass tort and class action experience, we handle both individual product-liability lawsuits and coordinated proceedings in large-scale litigation when they arise. Our team is focused on pursuing on your behalf the full amount of compensation you may be entitled to under the law. We have a proven record of successful results, with high-value settlements and verdicts that amount to billions of dollars.

Comprehensive, Client-Centered Approach to Legal Practice

At Anapol Weiss, we’re devoted to maximizing our clients’ recoveries while minimizing the stress of taking legal action. We create custom-tailored legal strategies for every client we serve, with their individual goals, needs, and priorities at the center of everything we do. Our mission isn’t just to handle cases, fight defendants, or secure potential financial compensation. It’s to give the injured a voice in the legal system.

Contact the Arrow IAB Catheter Lawsuit Lawyers at Anapol Weiss Today for a Free Case Review

Taking legal action can’t undo the harm you’ve suffered, but it can make a difference as your family moves forward. A defective medical device claim can provide the resources you need to access the best medical care available, offset the financial burden to your family, address your very real non-economic losses, and more. Standing up to the manufacturers of dangerous medical devices can also help bring greater accountability to the industry, improving the quality and safety of patient care.

For help from Teleflex Arrow FiberOptix and UltraFlex IAB catheter lawsuit attorneys with a nationally recognized reputation for taking on medical device manufacturers in court and getting results, contact Anapol Weiss online or call 215-735-1130today. The consultation is free and confidential, without risk, obligation, or stress.

Frequently Asked Questions About Teleflex Arrow IAB Catheter Lawsuits

When an intra-aortic balloon (IAB) catheter fails, it may not inflate or deflate properly, inflate at the wrong time, or stop working altogether. Because the device is intended to support a failing heart, any malfunction can reduce blood flow to vital organs, worsen cardiogenic shock, trigger dangerous blood pressure changes, or contribute to organ failure or cardiac arrest. In critically ill patients, even brief interruptions in support can be life-threatening.
An IAB catheter can sometimes fail without doctors realizing it right away, particularly if the device provides inaccurate pressure readings or appears functional despite internal defects.
Determining whether an IAB catheter contributed to injury or death often requires reviewing medical records, device data, and the timeline of events before and after the catheter was used. Sudden drops in blood pressure, unexplained organ failure, or rapid deterioration following placement or removal may raise concerns.
These connections are not always obvious to families, and individual hospitals’ notification practices regarding the use of recalled devices can vary, especially if the recall occurs later. An experienced medical device attorney can investigate whether device failure played a role in causing complications, injury, or patient death.
Yes. Patients who receive IAB catheters are often critically ill by definition, but that does not excuse a manufacturer from responsibility if a defective device worsened the patient’s condition or reduced their chance of survival. The legal question is not whether the patient was sick, but whether the catheter failed to perform as intended and caused additional harm.
Even when a patient faces serious underlying heart problems, a defective medical device may still be a substantial contributing factor to injury or death. If so, this fact can form the basis for a valid product liability claim.
Yes. If an IAB catheter malfunction contributed to a patient’s death, surviving family members may be able to file a wrongful death lawsuit. These claims are typically brought by a spouse, children, or the personal representative of the estate. Through legal action, you may be able to seek compensation for medical expenses, funeral costs, lost financial support, and loss of companionship.
Families do not need proof of medical device defects at the outset of the case, only a reasonable concern that device failure played a role. A lawyer can review records, consult experts, and determine whether the manufacturer or others may be legally responsible.
Multiple parties may be held liable for injuries caused by a defective IAB catheter. This can include the device manufacturer, companies involved in design or production, and, in some cases, distributors or suppliers. Liability may be based on design defects, manufacturing defects, or failure to warn about known risks. While hospitals and physicians are not usually responsible for product defects, they may be involved if errors occurred in handling or response.
A thorough investigation is often required to identify all responsible parties and pursue appropriate legal claims.
The time limit to file an IAB catheter lawsuit, known as the statute of limitations, varies by state and by the type of claim, such as personal injury or wrongful death. In many cases, the clock starts when the injury occurred or when it was reasonably discovered, not necessarily when the device was used.
Because medical device injuries and recalls are often identified later, delays can affect your rights. Speaking with an attorney as soon as possible helps ensure deadlines are met and important evidence is preserved.