Abiomed recalls Impella LD blood pumps (Product 005082) due to potential impeller blade damage from stent interaction, risking low blood 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 Impella LD blood pumps (Product Number 005:0082) because they might interact with a heart valve stent, causing impeller damage that could lead to low blood flow or embolization. This is a serious risk for patients using the device.
The pump's motor housing might interact with a stent used in a heart valve replacement, causing the impeller blades to break. This can lead to low blood flow and potentially embolized fragments traveling through the bloodstream.
Patients using the Impella LD blood pump for heart support are most at risk. The recall affects owners of the specific product model with Product Number 005082.
Check for the product name 'Impella LD' and Product Number 005082 on the pump's label or documentation. The device was sold with a unique identifier (UDI-DI: 00813502011227).
Immediately stop using the Impella LD blood pump if it is part of the recalled product line.
The pump's motor housing might interact with a stent used in a heart valve replacement, causing impeller blade damage that could lead to low blood flow or embolization.
Stop using it immediately and contact Abiomed for further instructions.
The recall record does not mention a fix or remedy; the remedy field is null.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2113-2023 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2113-2023 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.
