Impella 2.5 blood pump recalled due to impeller blade damage risk
Impella 2.5 intravascular blood pumps may experience unintended interaction with aortic valve replacement stents, damaging impeller blades and reducing blood flow. Fragments may circulate through the bloodstream.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall designation. Although no reported deaths or serious injuries are stated in the source text, the potential for serious patient harm through device failure and systemic embolization meets the Severe threshold and justifies the Class I classification.
Plain-English summary
Abiomed, Inc. is recalling approximately 9,252 units of the Impella 2.5 intravascular micro axial blood pump (Product Number 005042), with worldwide distribution including the United States.
The device motor housing may unintentionally interact with the distal stent of a transcatheter aortic valve replacement (TAVR), potentially destroying the impeller blades. This damage results in low blood flow from the Impella system. Fragments of the destroyed impeller may circulate through the bloodstream (systemic embolization).
This recall affects healthcare providers and patients with Impella 2.5 devices, particularly those who have had or may receive TAVR procedures.
The recalled product
- Product
- Impella 2.5 intravascular micro axial blood pump, Product Number 005042
- Manufacturer
- Abiomed, Inc.
- Affected units
- 9,252
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00813502011081
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Abiomed, Inc.
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FDA (Devices) · 2023-07-26
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