Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with serial numbers 150907W-191047W due to vibration risks causing pump failures. Affected units may show error codes or stop working unexpectedly.
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.
Arrow is recalling certain AutoCAT2 Intra-Aortic Balloon Pumps that could stop working or show error messages due to vibration issues. This risk could lead to the pump failing during medical use, which is serious.
Vibration can cause wires inside the pump to wear, overheat, or become damaged. This may trigger error messages on the device screen or cause the pump to stop working suddenly during medical use.
Healthcare professionals using the AutoCAT2 Intra-Aortic Balloon Pump for medical procedures are most at risk. Patients receiving this device during critical care may be affected if the pump fails.
Check the serial number on the pump's label. Affected units have serial numbers starting with 150907W through 191047W, as listed in the recall notice.
Look for the serial number on the pump's label to confirm if it falls within the affected range (150907W through 191047W).
The pump's internal wires can wear due to vibration, causing error messages or sudden failure during medical use.
Check the serial number to see if it's affected. If it is, contact Arrow International for further instructions.
The recall record does not specify a fix or remedy, so the manufacturer may need to be contacted for guidance.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2415-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2415-2020 from Arrow. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
