Agency classClass IOur severity:Severe FDA (Devices)·Z-3150-2026·Announced 2026-09-23

Abiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect

Abiomed is recalling Impella Optical Controllers because a purge flag component may fail, causing recognition issues. The recall covers 4,100 units distributed in the US and internationally.

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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly."

Plain-English summary

Abiomed, Inc. is recalling the Impella Optical Controller, Automated Impella Controller, and Impella Connect Package. The recall is due to a potential failure of the purge flag component within the purge pressure sensor assembly, which may result in purge cassette recognition issues.

The recall affects 4,100 units, including 2,785 units distributed in the United States and 1,315 units distributed outside the US. The products were distributed nationwide in the US and to numerous international markets, including Canada, the United Kingdom, Germany, Japan, and Australia.

No specific consumer actions are detailed in the source text beyond the identification of the affected product codes and serial numbers. Healthcare providers and facilities should verify their inventory against the provided product codes and serial number lists to identify affected units.

The recalled product

Product: Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA…
Manufacturer: Abiomed, Inc.
Category: Medical Device — Cardiac Support
Hazard: functional-defect
sensor-failure

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. Optical
AIC
Impella Connect
Packaged
AU
Product Code: 0042-0040-AU
UDI-DI: 00813502012972
Serial Numbers: IC12674
IC12675
IC13066
IC10162
IC10163
IC10387
IC10388
IC10747
IC10748
IC11472
IC11487
IC11489
IC11490

Distribution

Distributed nationwide across the United States.

Same manufacturer · Abiomed, Inc.

See all →

Severe
Abiomed Recalls 428 Automated Impella Controllers for Hardware and Software Defects
FDA (Devices) · 2026-11-04
Severe
Abiomed Recalls Impella Optical Controllers Due to Software and Hardware Defects
FDA (Devices) · 2026-11-04
Severe
Abiomed Recalls Impella Connect Optical AIC Units for Hardware and Software Defects
FDA (Devices) · 2026-11-04
High
Abiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects
FDA (Devices) · 2026-09-30
Severe
Abiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23

Same hazard · functional defect