Abiomed recalls Impella 5.0 blood pumps (Product 005062) due to potential impeller blade damage from TAVR stents, 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 Impella 5.0 blood pumps that could damage internal parts when used with certain heart valve implants, potentially causing blood clots or low blood flow. This is serious but only affects specific medical devices.
The pump's motor housing might interact with the TAVR stent, breaking the impeller blades. This can cause low blood flow and possible blood clots if fragments enter the bloodstream.
Patients using Impella 5.0 pumps with transcatheter aortic valve replacements (TAVR) are most at risk. Healthcare providers who use these pumps in medical procedures may also be affected.
Check for the product number 005062 on the pump's label. The device was sold with a unique identifier (UDI-DI: 00813502011180).
Look for the product number 005062 on the Impella 5.0 pump's label or packaging.
No, this recall only applies to specific medical procedures involving TAVR stents. The pump is safe for normal use without these implants.
Broken impeller blades can cause low blood flow and potential blood clots, which may require immediate medical attention.
Check the pump's label for product number 005062 or the unique identifier (UDI-DI: 00813502011180).
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2112-2023 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2112-2023 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.
