Agency classClass IOur severity:Severe FDA (Devices)·Z-0208-2027·Announced 2026-11-04

Abiomed Recalls 428 Automated Impella Controllers for Hardware and Software Defects

Abiomed is recalling 428 Automated Impella Controllers worldwide due to hardware and software defects that may cause pump control loss or calculation errors.

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 FDA classified this as a Class I recall due to a reasonable probability of serious adverse health consequences, specifically citing the potential loss of control of the heart pump console and pump drive failure. The source text does not report any illnesses, injuries, or deaths.

Plain-English summary

Abiomed, Inc. is recalling 428 units of the Automated Impella Controller (AIC), which serves as the primary user control interface for the Impella Catheter, a catheter-based heart pump. The recall covers units distributed worldwide, including the United States and numerous foreign countries.

A retrospective review of servicing records identified units requiring hardware, firmware, or software updates to address four specific issues. First, an RFID firmware issue may cause the AIC to fail to recognize the purge cassette during setup or changes, potentially delaying procedures. Second, a rotary push button may stick or actuate unreliably, impacting the operator's ability to select menu entries and potentially resulting in a loss of control of the console. Third, potential AIC instability could lead to start-up failure or an inability to drive the pump, necessitating a console exchange. Fourth, a software defect related to a calculator process crash may result in negative Central Venous Pressure values appearing in Pulmonary Artery Pressure calculations.

The source text does not report any illnesses, injuries, or deaths associated with these defects. Users should contact Abiomed for information on the required updates and servicing.

The recalled product

Product: Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
Manufacturer: Abiomed, Inc.
Category: Medical Device — Cardiac Support
Hazard: loss-of-control
software-defect
hardware-failure
Affected units: 428

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)

Product Code: 0042-0000-US
0042-0000-UK
0042-0000-EU
0042-0000-IN
0042-0000-CA
UDI:00813502010022
00813502011296
00813502011289
00813502011418
00813502011272
Serial No. IC1014
IC1029
IC1038
IC1043
IC1042
IC1061
IC1075
IC1096
IC1122
IC1190

Distribution

Distributed nationwide across the United States.

Same manufacturer · Abiomed, Inc.

See all →

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
Severe
Abiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23

Same hazard · loss of control