Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run times. Affected units may require immediate action 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 needing heart support.
The pumps have a potential issue with short battery run times, which could cause the device to fail during critical medical use. This might lead to inadequate heart support for patients requiring the pump.
Patients using the recalled cardiac pumps are most at risk. Healthcare providers who manage these devices may also be affected.
Check for the model name 'Arrow AutoCAT2' or 'AEROAUTOCAT 2 WAVE', reference number IAP-0535 (IPN000:00329), and lot/serial numbers listed in the recall notice.
Verify the product name and reference number on the pump's label to confirm if it's affected.
Reach out to Arrow International for specific instructions on next steps if the pump is affected.
The recall is due to potential short battery run times on the affected pumps, which could lead to device failure during critical medical use.
Check for the model name 'Arrow AutoCAT2' or 'AEROAUTOCAT 2 WAVE', reference number IAP-0535 (IPN000329), and lot/serial numbers listed in the recall notice.
Contact Arrow International for specific instructions on next steps if the pump is affected.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0431-2023 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0431-2023 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.