Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run times. Affected units may need replacement to prevent device failure.
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Arrow is recalling certain AutoCAT2 Intra-Aortic Balloon Pumps due to potential short battery run times. This could lead to device failure during use, which is critical for patients requiring cardiac support.
The pump may run out of battery faster than expected, potentially causing device failure during critical medical procedures. This could lead to complications for patients relying on the pump for cardiac support.
Patients using the recalled cardiac pump for medical treatment are most at risk. The recall affects specific model numbers and serial ranges sold in the U.S.
Check for the model name 'AutoCAT2' and serial numbers starting with 0801902 05174 5 or 6. The product was sold with specific UDI/DI codes.
Look for the serial number on the pump's label, which should start with 0801902 0517:4 5 or 6.
The recall is due to potential short battery run times on the affected pumps, which could lead to device failure during use.
Check the serial number on the pump's label; affected units have serial numbers starting with 0801902 05174 5 or 6.
The recall does not specify a remedy, so contact Arrow International for further instructions.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0428-2023 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0428-2023 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.
