Arrow recalls AutoCAT 2 intra-aortic balloon 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 AutoCAT 2 intra-aortic balloon pumps due to potential short battery run times. This could cause the device to fail during use, which is critical for patients requiring heart support.
The pumps may run out of battery faster than expected, potentially failing during critical medical use. This could lead to inadequate heart support for patients who rely on the device.
Patients using the affected cardiac pumps for heart support are most at risk. The recall applies to specific model numbers and serial ranges sold in the U.S.
Check for the model name 'Arrow AutoCAT 2 IABP' and serial numbers starting with 0801902 09205 2 or 0801902 09205 3. The recall covers specific lot numbers sold in the U.S.
Monitor the pump's battery level to ensure it doesn't run out unexpectedly during use.
Reach out to Arrow International for guidance on next steps if you own an affected pump.
The recall is due to potential short battery run times on the affected pumps, which could cause device failure during critical medical use.
Check for the model name 'Arrow AutoCAT 2 IABP' and serial numbers starting with 0801902 09205 2 or 0801902 09205 3.
Contact Arrow International for guidance on next steps, as the recall does not specify a replacement or repair process.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0445-2023 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0445-2023 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.