The Recall Desk
SevereFDA (Devices)·Z-2113-2023·Announced 2023-07-26

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Category
Medical Device — Cardiac / Circulatory Support
Hazard
  • mechanical-defect
  • embolization
  • device-incompatibility

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.

Related recalls

Same category