Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run times. Affected units may require immediate attention 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 critical medical procedures.
The affected pumps may run out of battery power unexpectedly during use. This could cause the device to stop working when it's needed for critical medical support.
Patients using the recalled cardiac pumps for medical treatment. Those with specific model numbers and serial tags are most at risk.
Check for the model AC3 IABP NA/AJLA with reference number IAP-0601 (IPN001109). Look for the UDI/DI codes: (01) 0 0801902 09118 5 or (01) 0 : 0801902 09118 6.
Verify the model number and reference code on the pump to confirm if it's affected.
The recall states there's a potential issue with short battery run times, which could cause the pump to stop working unexpectedly during medical use.
Check for the model AC3 IABP NA/AJLA with reference number IAP-0601 (IPN001109) and UDI/DI codes (01) 0 0801902 09118 5 or (01) 0 0801902 09118 6.
The recall does not specify a remedy, so contact Arrow International directly for guidance.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0435-2023 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0435-2023 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.