Impella LD cardiac pump recalled for impeller damage and embolization risk
Abiomed recalls Impella LD blood pumps due to potential interaction with aortic valve replacement devices that can damage the pump impeller and cause blood clots. Patients with these devices should contact their healthcare provider.
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 medical device recall, which requires a minimum severity score of 4 per the rubric. While no deaths or injuries have been reported, the potential hazards—pump failure resulting in inadequate blood flow and systemic embolization of fractured components—represent serious risks in a critical cardiac support device.
Plain-English summary
Abiomed, Inc. is recalling approximately 9,252 units of the Impella LD intravascular micro axial blood pump (Product Number 005082) distributed worldwide and throughout the United States.
The recalled pumps face a potential risk of unintended interaction between the device's motor housing and the distal stent of a transcatheter aortic valve replacement (TAVR) device. This interaction can result in destruction of the Impella's impeller blades, reducing blood flow through the pump system. Additionally, fractured impeller material could circulate through the bloodstream, posing a risk of blood clots.
This recall affects patients who have received both an Impella LD pump and a TAVR device. The interaction is most likely to occur when these two devices are positioned in close proximity within the patient's vasculature.
Patients who have received an Impella LD pump should contact their healthcare provider immediately to determine if they also have a TAVR device and to discuss whether their individual situation requires clinical intervention.
The recalled product
- Product
- Impella LD intravascular micro axial blood pump, Product Number 005082
- 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: 00813502011227
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.
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