Abiomed recalls 9 Impella CP SmartAssist blood pumps (Product No. 1000080) that failed inspection. These pumps may have been released without proper safety checks.
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Abiomed is recalling nine specific Impella CP SmartAssist blood pumps that failed inspection. These pumps could have been released without proper safety checks, posing a risk to users.
The pumps failed inspection and were inadvertently released, meaning they may not meet safety standards. This could lead to improper function or failure during use, potentially causing harm to the patient.
Patients using the recalled Impella CP pumps for left heart support are affected. Those with the specific product numbers listed are most at risk.
Check for the product number 1000080 (REF 0048-0003) on the pump. The specific serial numbers 504354 through 504363 are also listed in the recall.
Verify the product number and serial numbers listed in the recall to confirm if your pump is affected.
The pumps failed inspection and were inadvertently released, meaning they may not meet safety standards.
Check for the product number 1000080 (REF 0048-0003) and the specific serial numbers 504354 through 504363.
The recall does not specify a remedy, so contact Abiomed directly for further instructions.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2319-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2319-2024 from Abiomed. 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.
