Impella CP Blood Pump Recalled for Blade Destruction From Stent Interaction
Abiomed's Impella CP cardiac pump can be damaged by interaction with replacement heart valves, potentially causing blood clots. The FDA classified this as a Class I recall of 9,252 units worldwide.
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: This is an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric. While no injuries have been reported in the source, the device failure mechanism—motor housing contact with TAVR stents causing impeller blade destruction and potential systemic embolization—poses a serious health hazard to patients relying on cardiac support.
Plain-English summary
Abiomed, Inc. is recalling the Impella CP intravascular micro axial blood pump (Product Number 0048-0032), distributed worldwide including throughout the United States. The recall affects 9,252 units.
There is a potential risk that the Impella motor housing may interact unintentionally with the distal stent of a transcatheter aortic valve replacement (TAVR) device. When this occurs, the pump's impeller blades can be destroyed, resulting in low blood flow from the Impella system.
The destruction of the impeller blades can cause fractured material to enter the bloodstream, with systemic embolization being a potential consequence. The FDA classified this as a Class I recall, indicating a serious health hazard.
The recalled product
- Product
- Impella CP intravascular micro axial blood pump, Product Number 0048-0032
- 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: 00813502011388
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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- SevereABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
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