Abiomed recalls Impella 5.5 SmartAssist pumps with specific product numbers 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 5.5 SmartAssist blood pumps with product numbers 0550-0008 and 1000100. The pumps could damage impeller blades when used with certain heart valve implants, leading to low blood flow or blood clots.
The pump's motor housing might interact with the TAVR stent, causing impeller blades to break. This can reduce blood flow and potentially release small pieces of metal into the bloodstream.
Patients using the Impella 5.5 SmartAssist pump for heart support are most at risk, particularly those with transcatheter aortic valve replacements (TAVR).
Check for product numbers 0550-0008 or 1000100 on the pump. The recall applies to pumps sold with UDI-DI codes 00813502011531 or 00813502012828.
Look for product numbers 0550-0008 or 1000100 on the pump.
The pump's motor housing could interact with the TAVR stent, causing impeller blades to break and potentially leading to low blood flow or blood clots.
Check for product numbers 0550-0008 or 1000100 on the pump, or UDI-DI codes 00813502011531 or 00813502012828.
The recall does not require immediate stop use; however, patients should contact Abiomed 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-2114-2023 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2114-2023 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.
