Intra-aortic balloon (IABs) catheters are life-sustaining medical devices used with balloon pumps in some of the most critical hospital settings. When these devices fail, the consequences can be devastating. Recently, the FDA issued a Class I recall, its most serious designation, for certain Teleflex/Arrow International IAB catheter kits after discovering a manufacturing defect that may put patients at risk of serious injury or death. Patients who received circulatory support using one of the recalled catheter kits should speak with their healthcare providers about possible complications and whether additional monitoring or follow-up care is appropriate.
Arrow IAB Catheters Recalled Over Serious Safety Risks
The FDA Class I recall applies to the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, with nearly 17,000 devices distributed in the United States between May 2022 and April 2024. These devices are commonly used in patients undergoing cardiac or non-cardiac surgery and in adults experiencing acute coronary syndrome or complications of heart failure.
The recall was issued after Teleflex and its subsidiary, Arrow International, found a manufacturing error that may cause the catheter’s balloon to become over-twisted, which can interfere with proper function. This defect may prevent the balloon from fully inflating, cause blood to back up into the tubing, allow helium to leak, or result in catheter damage or insertion difficulties. In some cases, the problem may not be visible before use, meaning a device can malfunction even after standard inspection. The risks associated with these failures are severe and include blood loss, arterial perforation, unstable blood pressure, reduced blood flow to the heart, and death.
So far, Teleflex and Arrow International have reported 322 complaints, including 31 injuries and 3 deaths, potentially linked to this issue.
Why This Recall Matters for Patients and Families
In critical care settings, there is often little margin for error. A malfunctioning intra-aortic balloon catheter can worsen an already life-threatening situation, leaving patients and families to deal with unexpected injuries, extended hospitalizations, or worse. Even when complications are survived, the physical, emotional, and financial toll can be overwhelming.
If you or someone you love were harmed after treatment involving a recalled intra-aortic balloon catheter, you do not have to face the aftermath alone. Our law firm is currently investigating potential Teleflex Arrow IAB Catheter lawsuits. Call Anapol Weiss at 215-735-1130 or fill out our online contact form to schedule a free consultation with one of our product liability lawyers.
Disclaimer: This blog is intended for informational purposes only and does not establish an attorney-client relationship. It should not be considered as legal advice. For personalized legal assistance, please consult our team directly.
