Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Recall: Risk of Serious Health

The FDA announced on April 29, 2024, that ARROW INTERNATIONAL Inc. is recalling Arrow FiberOptix Intra-Aortic Balloon Catheter Kits due to potential failure of the balloon to inflate or damage to the central lumen. The agency classified the recall as Class I. Owners should contact Teleflex for information.

How to tell if you have it

• Arrow FiberOptix Intra-Aortic Balloon Catheter Kit, REF IAB-05830-LWS
• Arrow FiberOptix Intra-Aortic Balloon Catheter Kit, REF IAB-05840-LWS
• Arrow FiberOptix Intra-Aortic Balloon Catheter Kit, REF IAB-05850-LWS

The hazard

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as failure of the intra-aortic balloon to completely inflate over its full length, damaged or broken central lumen in the segment contained within the balloon, or helium loss or blood in the helium pathway.

Context

GovInfoNow's records show ARROW INTERNATIONAL Inc. has 52 other recalls on record since June 1, 2017. Other recent recalls of similar products include Arrow Arterial Kits and Trays (July 26, 2024), ARROW QuickFlash Radial Artery Catheter Recall (Feb. 12, 2024), and Arrow ErgoPack PICC Kit Recall (Aug. 10, 2023). Other recent recalls of similar products include Arrow CVC Kits Recall (April 21, 2026), Arrow Radial Artery Catheter Kit Recall (March 11, 2026), and Arrow PI Midline 2L Catheter Recall (April 21, 2026).