Agency classClass IOur severity:Severe FDA (Devices)·Z-2360-2026·Announced 2026-06-24

Automated Impella Controller software error affects left ventricular support devices

Automated Impella Controllers are being recalled because of a potential software error when used with left ventricular Impella devices. 10,297 units are affected.

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 Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

The Automated Impella Controller (AIC), for use with a left heart support blood pump, from Abiomed, Inc., is being recalled across the product codes listed in the recall notice, including 0042-0000-AU. The action covers 10,297 units running software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above.

The stated reason is a potential software error in the Automated Impella Controller when used in conjunction with left ventricular Impella devices. The FDA classified the action as Class I, its most serious classification.

Distribution was worldwide, including nationwide in the United States and to Australia, Austria, Belgium, Brazil, Canada, China and other markets. The controllers are used in healthcare facilities rather than sold to consumers.

Facilities should identify affected controllers using the product codes, GTINs, serial numbers and software versions in the recall notice and follow the instructions issued by Abiomed.

The recalled product

Product: Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.…
Manufacturer: Abiomed, Inc.
Category: Medical Device — Circulatory support controller
Hazard: software-error
circulatory-support
class-i
Affected units: 10,297

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)

All products below with software versions 6.0.1
6.0.2
6.0.3
7.1 and above. 1. Product Code: 0042-0000-AU
GTIN: 00813502010886
Serial Numbers: IC5341
IC5523
IC5677
IC6531
IC5525
IC6529
IC5836
IC5524
IC7849
IC7850
IC7287
IC7288
IC7289
IC7290
IC6527

Distribution

Distributed nationwide across the United States.

Same manufacturer · Abiomed, Inc.

See all →

High
Abiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects
FDA (Devices) · 2026-09-30
Severe
Abiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
Severe
Abiomed Recalls Impella Optical Controllers Due to Purge Flag Component Failure
FDA (Devices) · 2026-09-23
Severe
Abiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
Severe
ABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22

Same hazard · software error