Agency classClass IOur severity:Severe FDA (Devices)·Z-2112-2023·Announced 2023-07-26

Impella 5.0 Blood Pump Recalled for Potential Impeller Blade Destruction Risk

Abiomed's Impella 5.0 intravascular blood pump is recalled due to risk of impeller blade destruction when interacting with heart valve replacements. The damaged pump can cause reduced blood flow and potentially release fractured material into 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 classifies this as Class I, which mandates a minimum severity of Severe per the rubric. Although no patient illnesses or injuries have been reported, the Class I designation reflects serious potential for harm in a critical life-support device.

Plain-English summary

Abiomed, Inc. is recalling approximately 9,252 units of the Impella 5.0 intravascular micro axial blood pump (Product Number 005062) distributed worldwide and throughout the United States. The Impella 5.0 is a cardiac support device designed to temporarily assist the heart's pumping function.

The recall stems from a potential risk of unintended interaction between the pump's motor housing and the distal stent of a transcatheter aortic valve replacement (TAVR). This interaction can cause destruction of the pump's impeller blades, resulting in reduced blood flow from the device. Systemic embolization—the potential release of fractured impeller material into the bloodstream—poses an additional risk.

Patients with both an Impella 5.0 pump and a TAVR in place may be at risk. Healthcare providers should evaluate whether affected patients require clinical intervention, device inspection, or replacement. The FDA classified this recall as Class I, indicating serious potential for adverse health consequences.

The recalled product

Product: Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Manufacturer: Abiomed, Inc.
Category: Medical Device — Cardiac Support Device
Hazard: impeller-damage
systemic-embolization
hemodynamic-failure
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: 00813502011180

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 →

Same manufacturer · Abiomed, Inc.

See all →

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Abiomed Recalls Impella Optical Controllers Due to Purge Flag Component Failure
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Abiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
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ABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
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Same hazard · impeller damage