Arrow recalls specific models of AutoCAT2 Intra-Aortic Balloon Pumps due to vibration causing motor connector issues that may lead to pump failure or alarms.
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 models of AutoCAT2 Intra-Aortic Balloon Pumps because a component can vibrate and cause motor connector damage, potentially leading to pump failure or alarms. This could affect patients using the device and requires immediate attention to prevent serious complications.
The pump's motor connector wires can vibrate and cause fretting, charring, and discoloration. This may trigger system alarms (like System Error 3 or High Baseline) and could lead to sudden pump failure or inability to start the device.
Patients using the recalled AutoCAT2 Intra-Aortic Balloon Pumps are most at risk. Healthcare providers who use these devices for medical treatments may also be affected.
Check for the product code IAP-0500J and serial numbers listed in the recall notice. The affected models include specific ranges like 140866W through 140867W, 150117W through 150118W, and others.
Look for the serial number on the pump's label to see if it matches the listed ranges.
Reach out to Arrow International for guidance on next steps if the pump is affected.
The pump's motor connector wires can vibrate and cause damage, potentially leading to alarms or sudden failure.
Check the serial number against the listed ranges and contact Arrow International for further instructions.
The recall addresses potential pump failure, which could affect patient safety, but the remedy does not specify immediate stop-use.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2413-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2413-2020 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.
