Abiomed Impella 5.5 pump recalled due to impeller blade damage risk
Abiomed is recalling the Impella 5.5 with SmartAssist pump due to a risk of impeller blade destruction when used with aortic valve replacement devices. Damage can result in low blood flow and systemic embolization, where broken pump pieces may enter 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 designation requires a minimum severity score of 4. The recall involves potential destruction of critical pump components and risk of systemic embolization, though the source does not report any actual injuries or deaths.
Plain-English summary
The Impella 5.5 with SmartAssist is a small mechanical pump inserted into the heart to assist blood flow. The FDA has classified this recall as Class I due to a potential interaction between the pump's motor housing and stents used in transcatheter aortic valve replacement (TAVR) procedures.
When the motor housing unintentionally contacts the aortic valve stent, it can destroy the impeller blades inside the pump. This damage reduces the pump's ability to circulate blood effectively, resulting in low blood flow. Additionally, fractured pieces of the impeller blades may enter the bloodstream, posing a risk of systemic embolization.
The affected devices have been distributed worldwide, including throughout the United States.
The recalled product
- Product
- Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Cardiac Support
- 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 (2)
- UDI-DI: 00813502011531
- 00813502012828
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
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