Teleflex Has Class I Balloon Catheter Recall, 3 Deaths Reported

Teleflex’s recall of Arrow FiberOptix and UltraFlex intra-aortic balloon (IAB) catheter kits over a manufacturing issue has been deemed Class I by the U.S. Food and Drug Administration (FDA).
 
The catheter kits were recalled after Teleflex discovered a manufacturing error that can cause the catheter’s balloon to become over-twisted. The issue can sometimes be spotted visually but a device may still be affected even if it’s not seen.
 
The over-twisting can prevent the balloon from fully inflating, cause blood to back up in the tubing, allow helium leakage, and lead to catheter damage or difficulty inserting during use.
 
Using the device may cause blood loss, perforation, hemodynamic instability, myocardial ischemia, or death. The company has reported 322 complaints related to the issue, with 31 injuries and three deaths.
 
Teleflex’s April 29 Urgical Medical Device Notification Letter urged customers to have a backup IAB available before using the affected device, in case a replacement is needed. All IAB catheters in the recall’s scope should be inspected for signs of an overtwisted balloon wrap or bent balloon shaft before use.
 
Over-twisting can be recognized by a progressive pitch or tightness in the helical wrap at the balloon’s distal or proximal end. Catheters suspected of having an over-twisted wrap should not be inserted.
 
Further, Teleflex suggested using fluoroscopic guidance to insert all IAB catheters in the recall’s scope. It should be used to assess the completeness of balloon inflation, spanning the balloon’s full length and including several inflation/deflation cycles.
 
Customers should also remain vigilant in responding to pump alarms and bedside indicators that the IAB isn’t performing as expected.

More about the recalled devices

The Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kit are used with a balloon pump and together are used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure.