Official recall notice

FDA DeviceClass INotable

Abiomed Impella CP Set with SmartAssist Recall (Jul 2026)

Product: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.

Recall date
2026-07-01
FDA class
Class I

Why it was recalled

Hazard

Potential for thrombus formation during prolonged use of the introducer.

One email a week when there are new recalls. Confirm by email; unsubscribe anytime.

Product description

Potential for thrombus formation during prolonged use of the introducer.

Affected products

Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.

Verify with the official notice →
Share:

Related Recalls

2026-09-30 · FDA_DEVICE
FDA Recall: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod
Abiomed, Inc.
2026-09-23 · FDA_DEVICE
FDA Recall: Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. I
Abiomed, Inc.
2026-09-23 · FDA_DEVICE
FDA Recall: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod
Abiomed, Inc.
2026-09-23 · FDA_DEVICE
FDA Recall: Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below pro
Abiomed, Inc.