Arrow recalls AC3 Optimus IABP cardiac pumps with potential short battery run times. Affected units may need replacement to prevent device failure during critical medical use.
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Arrow is recalling certain AC3 Optimus intra-aortic balloon pumps due to potential short battery run times. This could cause the pump to fail during critical medical procedures if the battery runs out unexpectedly.
The pumps may run out of battery unexpectedly during critical medical procedures. This could cause the pump to stop working when the patient needs it most, potentially leading to serious complications.
Patients using the recalled cardiac pumps for heart support are most at risk. Healthcare providers who use these pumps in medical settings may also be affected.
Check for the model number AC3 Optimus IABP NA/EMEA with reference number IAP-0700 (IPN001112). The product has a unique identifier starting with UDI/DI (01) 0 0801902 08496 followed by a serial number.
Look for the model number AC3 Optimus IABP NA/EMEA with reference number IAP-0700 (IPN001112) on the device.
The recall is due to potential short battery run times that could cause the pump to fail during critical medical procedures.
Check for the model number AC3 Optimus IABP NA/EMEA with reference number IAP-0700 (IPN001112) and the unique identifier starting with UDI/DI (01) 0 0801902 08496.
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-0438-2023 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0438-2023 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.