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The Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits are being recalled for manufacturing issues that may prevent full balloon inflation and cause patient harm
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Teleflex and Arrow International recall ARROW Endurance Extended Dwell peripheral catheter system due to risk of catheter separation and leakage
Arrow International, LLC, a Subsidiary of Teleflex, Inc, recalls Arrow AutoCAT 2, AC3 intra-aortic balloon pumps for unexpectedly short battery run times