Arrow recalls AutoCAT2 IABP pumps with serial numbers 160516W to 170302W due to vibration causing motor connector issues that may lead to pump failure.
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 because a component can fail from vibration, causing alarms or sudden stoppage of the pump. This is serious for patients relying on the device for life support.
Vibration can cause motor connector wires to fret, char, and discolor. This may trigger pump alarms (System Error 3 or High Baseline) and cause the pump to stop working suddenly, risking patient safety.
Patients using the recalled pumps for life support are most at risk. Healthcare providers who use these pumps in medical settings may also be affected.
Check the serial number on the pump. Recalled units have serial numbers starting with 160516W through 170302W (specific ranges listed in the recall notice).
Immediately stop using the pump if it has a recalled serial number. The pump may stop working suddenly or give false alarms.
Recalled units have serial numbers starting with 160516W through 170302W (specific ranges: 160516W, 160619W, 160804W, 160828W, 170209W through 170210W, 170302W, 180309W).
A component in the pump can fail from vibration, causing motor connector wires to fret, char, and discolor. This may lead to pump alarms or sudden stoppage of function.
Immediately stop using the pump and contact Arrow International for instructions on replacement or repair.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2412-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2412-2020 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.
