The Recall Desk
SevereFDA (Devices)·Z-2111-2023·Announced 2023-07-26

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.

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: 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.
Category
Medical Device — Cardiac Support Device
Hazard
  • impeller-damage
  • embolization
  • low-blood-flow

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.

Related recalls

Same category