Agency classClass IOur severity:Severe FDA (Devices)·Z-2601-2026·Announced 2026-07-01

Abiomed Impella CP Set with SmartAssist 10th Generation Introducer Kits Recalled

Abiomed is recalling certain Impella CP Set with SmartAssist (10th Generation) units with affected 14Fr Low Profile Introducer Kits due to potential for thrombus (blood clot) formation during prolonged use.

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 of a medical device with a hazard (thrombus formation) that poses risk of serious injury or death in a high-risk patient population undergoing cardiac support. Although no reported illnesses are stated in the source text, the serious nature of the hazard—blood clot formation during use of a critical circulatory support device—and the Class I designation require a Severe rating per the rubric.

Plain-English summary

Abiomed, Inc. is recalling certain Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. The affected product codes are 1000413 and 1000834. The recall is due to a potential for thrombus (blood clot) formation during prolonged use of the introducer.

A total of 168 units have been distributed worldwide. In the United States, distribution occurred in Florida, Illinois, Minnesota, New Jersey, New York, and Virginia. Additional units were distributed to Japan. Patients and healthcare providers who have received these units should contact Abiomed for further instructions.

Healthcare providers should discontinue use of affected units and review patient records to identify those who received recalled introducers. Patients who received this product should consult with their healthcare provider about the recall and any potential risks related to their care.

The recalled product

Product: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Manufacturer: Abiomed, Inc.
Category: Medical Device — Cardiac Support / Circulatory Assist Device
Hazard: thrombus
blood-clot-formation
Affected units: 168

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 (20)

1. Impella Set Product Code: 1000413
GTIN: 00813502013566
Serial numbers: 649727
649728
649729
649730
649731
654349
654348
654342
654341
654340
654339
654338
654336
654335
654334
654333
653010
653009

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Abiomed, Inc.

See all →

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Same hazard · thrombus