Agency classClass IOur severity:Severe FDA (Devices)·Z-2116-2023·Announced 2023-07-26

Impella CP cardiac pump recalls due to motor housing interaction with stents

Abiomed is recalling Impella CP with SmartAssist blood pumps due to risk of motor housing interaction with transcatheter aortic valve replacement devices, which can damage the pump's impeller blades and reduce blood flow.

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 recall, the agency's most serious classification. Although no illnesses or injuries are reported in the source text, FDA Class I classification requires a minimum severity score of 4. The hazard involves potential life-threatening complications in a cardiac support device, including reduced blood flow and systemic embolization risk.

Plain-English summary

Abiomed, Inc. is recalling the Impella CP with SmartAssist intravascular micro axial blood pump due to a potential safety risk. The recalled devices have product numbers 0048-0024, 0048-0045, and 1000080. Approximately 9,252 units have been distributed worldwide, including throughout the United States.

The motor housing of the Impella pump may unintentionally interact with the distal stent of a transcatheter aortic valve replacement (TAVR) device. When this interaction occurs, it can destroy the impeller blades, resulting in low blood flow output from the pump. The destruction of the impeller blades also creates the potential for systemic embolization—the circulation of fractured impeller fragments in the bloodstream—which poses a risk to patient safety.

The recalled product

Product: Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
Manufacturer: Abiomed, Inc.
Category: Medical Device — Cardiac Assist Device
Hazard: impeller-damage
low-flow
systemic-embolization
device-interaction
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 (3)

UDI-DI: 00813502011371
00813502011876
00813502012279

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.

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Same hazard · impeller damage