Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with specific serial numbers due to vibration risks causing pump alarms or failure. Affected units may need repair or replacement.
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 due to vibration issues. This risk affects patients using the pumps for heart support, potentially causing life-threatening failures.
Vibration can cause internal components to wear, leading to pump alarms or sudden failure. This may stop the pump from working during critical medical procedures, risking patient safety.
Patients using the AutoCAT2 Intra-Aortic Balloon Pump for heart support are most at risk. The recall applies to specific serial number ranges produced between 2015 and 2016.
Check the serial number on your pump. Affected units have serial numbers starting with 150301V through 160643V, produced between 2015 and 2016.
Look for the serial number on the pump's label to confirm if it falls within the affected range.
Reach out to Arrow International for guidance on next steps if your pump is affected.
The pump's internal components may fail due to vibration, causing alarms or sudden stoppage of function.
Contact Arrow International for instructions on repair or replacement options.
Yes, affected units have serial numbers starting with 150301V through 160643V.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2409-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2409-2020 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.
