Arrow recalls AC3 Optimus IABP cardiac pumps with potential short battery run times. Affected units may require immediate action 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 AC3 Optimus intra-aortic balloon pumps due to potential short battery run times. This could cause the device to fail during critical medical use, putting patients at risk.
The pumps may run out of battery power unexpectedly during use. This could cause the device to stop working when it's needed to support heart function.
Patients using the recalled cardiac pumps are most at risk. Healthcare providers who have these devices in their facilities may also need to take action.
Check for the UDI/DI code (01) 2 0801902 17206 2 or (01) 2 0801902 17206 5 on the device. The product was sold with specific lot/serial numbers as listed in the recall notice.
Verify if the device has been running out of battery unexpectedly during medical procedures.
Reach out to Arrow International for specific guidance on the affected units.
The recall is due to potential short battery run times on the affected intra-aortic balloon pumps, which could cause device failure during critical medical use.
Check for the UDI/DI code (01) 2 0801902 17206 2 or (01) 2 0801902 17206 5 on the device. The product was sold with specific lot/serial numbers as listed in the recall notice.
Contact Arrow International for specific guidance on the affected units. The recall does not specify immediate action steps beyond manufacturer contact.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0439-2023 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0439-2023 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.
