Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE Recalled by Arrow International Inc Due to A potential issue with a component within the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International Inc directly.
Affected Products
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Quantity: 2123 total
Why Was This Recalled?
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
Where Was This Sold?
Worldwide distribution.
About Arrow International Inc
Arrow International Inc has 431 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report