Abiomed recalls Impella CP SmartAssist pumps with specific product numbers due to potential impeller blade destruction from TAVR stent interaction, risking blood clots and low blood flow.
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
Abiomed is recalling certain Impella CP SmartAssist blood pumps because they might break when used with a specific type of heart valve implant, causing blood clots and low blood flow. This could lead to serious health issues if the pump fails during use.
The pump's motor housing might interact with the TAVR stent, causing the impeller blades to break. This can lead to low blood flow and potential blood clots that could travel through the bloodstream.
Patients using the recalled Impella CP pumps for heart support are most at risk, particularly those with transcatheter aortic valve replacements (TAVR).
Check the product numbers on the pump: 0048-0024, 0048-0045, or 1000080. The pumps were sold with specific UDI-DI codes listed in the recall notice.
Look for the product numbers 0048-0024, 0048-0045, or 1000080 on the pump packaging or device.
The pump's motor housing might interact with the TAVR stent, causing impeller blades to break, which can lead to low blood flow and blood clots.
Check the product numbers: 0048-0024, 0048-0045, or 1000080. The pumps were sold with specific UDI-DI codes listed in the recall notice.
The recall does not specify a remedy, so contact Abiomed directly for guidance on next steps.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2116-2023 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2116-2023 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.
