Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with specific serial numbers due to vibration risks causing pump alarms or failure. Affected units may need replacement to prevent medical emergencies.
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 may malfunction due to vibration causing alarms or sudden stoppage. This could lead to serious medical risks if the pump fails during use.
Vibration can cause internal components to wear, leading to alarms like System Error 3 or High Baseline. If severe enough, this may cause the pump to stop working suddenly, risking patient safety.
Patients using the recalled pumps, particularly those on life support who rely on the device's continuous operation. Medical professionals managing these patients are at highest risk.
Check for serial numbers starting with 150302W through 190633W as listed in the recall notice. The product is the Arrow AutoCAT2 Intra-Aortic Balloon Pump in Spanish language versions.
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 the pump is affected.
The pump's internal components may fail due to vibration, causing alarms or sudden stoppage that could endanger patients.
Check the serial number against the list provided in the recall notice. If affected, contact Arrow International for instructions.
The recall indicates a potential risk, so affected units should not be used until the manufacturer provides a solution.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2411-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2411-2020 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.
