Abiomed recalls Impella 2.5 blood pumps with potential risk of impeller damage during TAVR procedures, causing low flow or embolization.
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 Impella 2.5 blood pumps that could damage the impeller blades during transcatheter aortic valve replacement (TAVR) procedures. This might cause low blood flow or embolization of broken parts.
The pump's motor housing might interact with the TAVR stent, breaking the impeller blades. This can cause low blood flow and potentially release broken parts into the bloodstream.
Patients receiving TAVR procedures using the recalled Impella 2.5 pumps are most at risk. Healthcare providers using these pumps for cardiac support are also affected.
The recalled product is the Impella 2.5 blood pump with Product Number 005042. It was sold with UDI-DI: 00813502011081.
Verify if your Impella 2.5 pump has Product Number 005042 or UDI-DI: 00813502011081.
The recall is specific to TAVR procedures, not regular use. The hazard only occurs during certain medical procedures.
The recall record does not specify a remedy, so contact Abiomed directly for guidance.
The recall states systemic embolization of fractured impeller material is a possibility, which could be serious.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2111-2023 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2111-2023 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.
