Arrow recalls AutoCAT2 IABP 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 AutoCAT2 Intra-Aortic Balloon Pumps that may have short battery run-times. This could lead to device failure during medical use, potentially causing harm to patients.
The pumps may run out of battery power unexpectedly during medical procedures. This could cause the device to stop working when it's needed to support a patient's heart.
Patients using the recalled cardiac pumps for medical treatment are most at risk. Healthcare providers who use these pumps in hospitals may also be affected.
Check for the model number 'AutoCAT2 WAVE REFURBISHED' with serial numbers starting with (01) 0 0801902 09391. The product was sold with specific lot/serial numbers listed in the recall notice.
Verify the model number and serial numbers match the affected units described in the recall.
Reach out to Arrow International for guidance on next steps if you have the recalled product.
The recall indicates potential short battery run-times, so it's not recommended for use until the manufacturer provides a solution.
Check for the model number 'AutoCAT2 WAVE REFURBISHED' with serial numbers starting with (01) 0 0801902 09391 as listed in the recall notice.
Contact Arrow International for guidance on next steps if you have the recalled product.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0430-2023 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0430-2023 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.
