Arrow recalls AutoCAT 2 intra-aortic balloon pumps with potential short battery run times. Affected units may need replacement to prevent device failure during use.
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Arrow is recalling certain AutoCAT 2 intra-aortic balloon pumps due to potential short battery run times. This could cause the device to fail during use, risking patient safety.
The pumps may run out of battery faster than expected, potentially causing the device to stop working during critical medical procedures. This could lead to complications for patients needing the pump.
Patients using the recalled cardiac pumps are affected. Those with the specific model and serial numbers listed in the recall are most at risk.
Check for the model name 'Arrow AutoCAT 2 IABP', reference number IAP-0400E (IPN000305), and specific serial numbers listed in the recall notice.
Look for the serial number on the pump's label, which should match the numbers listed in the recall notice.
Reach out to Arrow International for guidance on next steps if you have the recalled pump.
The recall is due to potential short battery run times that could cause the device to fail during use.
Check for the model name 'Arrow AutoCAT 2 IABP', reference number IAP-0400E (IPN000305), and specific serial numbers listed in the recall notice.
Contact Arrow International for guidance on next steps if you have the recalled pump.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0444-2023 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0444-2023 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.