Teleflex and Arrow International’s recall of the Arrow FiberOptix and Arrow UltraFlex intra-aortic balloon (IAB) catheter kits has been identified as Class I, the most serious type, the U.S. Food and Drug Administration (FDA) announced Thursday. The agency noted that this recall is a correction, not a product removal. Use of devices subject to a Class I recall correction “may cause serious injuries, serious health consequences, or death” if the correction is not made, according to FDA. Teleflex and its subsidiary Arrow International issued the recall April 29 when a manufacturing error that could cause the catheter’s balloon to become overly twisted was discovered. This defect can be visually identified, but not always. Overtwisted balloons may not be able to inflate fully, cause blood to back up into the tubing, allow helium to leak, and result in damage to or difficulty inserting the catheter. The manufacturer sent an Urgent Medical Device Notification letter to customers with several recommendations. These include: Have a backup IAB catheter available before using one of the recalled devices. Inspect all recalled IAB catheters for signs of an over-twisted balloon wrap. Overtwisting presents as a progressive pitch or tightness within the helical wrap at either end of the balloon. Catheters with visual signs of overtwisting should not be inserted. Use fluoroscopic guidance to insert any recalled IAB catheter. Continue to use fluoroscopy to assess completeness of balloon inflation, spanning the full length of the balloon, including several cycles of inflation/deflation. Continue intermittent fluoroscopy for up to 3 minutes after 1:1 cyclic counterpulsation begins or until full balloon inflation is confirmed. If a red-condition alarm sounds while an Arrow AC3 or Autocat-2 pump is used, immediate attention is needed, as stated in the Instructions for Use. Any pump alarm indicating a helium leak may mean the IAB catheter is not performing as it should. If an issue is identified while a recalled device is being used, the catheter should immediately be removed and replaced following the steps given in the Instructions for Use. Every suspected incidence of this condition should be reported to Teleflex as soon as possible. The affected products were distributed between May 7, 2022, and April 8, 2024, affecting a total of 16,959 devices. For more information, contact Teleflex/Arrow International Customer Service at (866) 396-2111 or recalls@teleflex.com. Adverse reactions or quality problems may also be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Image Credit: Svetlana – stock.adobe.com