Arrow recalls AC3 Optimus IABP pumps with potential short battery life. Affected units may need replacement to prevent cardiac pump 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 cardiac pumps that may run out of battery too quickly. This could cause the pump to stop working during critical medical procedures, risking serious harm to patients.
The pumps may run out of battery faster than expected, causing the device to stop working during medical procedures. This could lead to serious complications for patients with heart conditions who rely on the pump.
Patients using the Arrow AC3 Optimus IABP cardiac pump for heart support are most at risk. Healthcare providers who use these pumps in hospitals may also be affected.
Check for the model name 'AC3 Optimus IABP NA/AJLA' and reference number 'IAP-0701 (IPN916549)'. The device has a unique identifier (UDI/DI) starting with (01) 1 0801902 18178 followed by 4 or 7 digits.
Look for the UDI/DI code starting with (01) 1 0801902 18178 followed by 4 or 7 digits on the pump.
Reach out to Arrow International for specific guidance on whether your pump is affected and next steps.
Yes, the pump may stop working too soon, which could cause serious harm during medical procedures.
Check for the model name 'AC3 Optimus IABP NA/AJLA' and reference number 'IAP-0701 (IPN916549)' with the specific UDI/DI code.
Contact Arrow International directly to determine if your pump is affected and get instructions.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0442-2023 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0442-2023 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.