Abiomed recalls Impella CP blood pumps (Product 0048-0032) due to potential impeller blade damage from stent interaction, risking low flow and 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 its Impella CP blood pumps (Product Number 0048-0032) because a stent in some heart valve procedures might damage the pump's impeller blades. This could cause low blood flow or pieces of the pump to travel through the bloodstream.
The pump's motor housing might interact with a stent used in a heart valve procedure. This interaction can break the impeller blades, causing low blood flow or small pieces of the pump to enter the bloodstream.
Patients using the Impella CP blood pump for heart support are most at risk. Healthcare providers who have this pump in their medical equipment may also be affected.
Check for the product number 0048-0032 on the Impella CP blood pump. This pump was sold with a unique identifier (UDI-DI: 00813502011388).
Look for the product number 0048-0032 on the Impella CP blood pump.
The pump's motor housing might interact with a stent used in a heart valve procedure, potentially damaging the impeller blades and causing low blood flow or embolization.
The recall record does not specify a remedy, so check with your healthcare provider or Abiomed for guidance.
The recall record states there is a potential risk of impeller damage, so it is not safe to use without checking with Abiomed.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2115-2023 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2115-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
