Arrow recalls AutoCAT2 Intra-Aortic Balloon Pump models with serial numbers 140861W-151030W to prevent vibration-related motor connector failures that could cause pump alarms or sudden shutdowns.
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 specific models of AutoCAT2 Intra-Aortic Balloon Pumps due to a vibration issue that may cause motor connector wires to fail, leading to pump alarms or sudden shutdowns. This could be dangerous for patients using the device.
Vibration can cause motor connector wires to fret, char, and discolor, which may trigger pump alarms (System Error 3 and High Baseline) or cause the pump to stop working suddenly. This could lead to medical complications if the pump fails during treatment.
Patients using the recalled AutoCAT2 Intra-Aortic Balloon Pumps for medical treatment are most at risk. The device is used in critical care settings, so affected individuals should check if their pump is in the listed serial number ranges.
Check your pump's serial number against the list of affected numbers provided in the recall notice. The affected models are Arrow AutoCAT2 Intra-Aortic Balloon Pumps with Product Code IAP-0500 and serial numbers in the ranges listed.
Look for the serial number on your pump's label and compare it to the list of affected serial numbers provided in the recall notice.
The pump's motor connector wires may fail due to vibration, causing alarms or sudden shutdowns that could affect medical treatment.
Check your pump's serial number against the list of affected numbers. If it's in the list, contact Arrow International for further instructions.
The recall notice does not specify a fix or remedy; it only lists affected models and advises checking the serial number.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2410-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2410-2020 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.
