Agency classClass IOur severity:Severe FDA (Devices)·Z-0209-2027·Announced 2026-11-04

Abiomed Recalls Impella Optical Controllers Due to Software and Hardware Defects

Abiomed is recalling 179 Impella Optical Controllers worldwide due to defects that may cause pump failure, loss of control, or inaccurate pressure readings.

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 recall is classified as Class I due to hazards including loss of control of the heart pump console and pump failure. The source text does not report any illnesses, injuries, or deaths.

Plain-English summary

Abiomed, Inc. is recalling 179 units of the Impella Optical Controller, the primary user control interface for the Impella Catheter, a catheter-based heart pump. The recall covers units distributed in the United States and 30 foreign countries, including Belgium, Brazil, Canada, and the United Kingdom.

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 controller to fail to recognize the purge cassette, potentially delaying procedures. Second, the rotary push button may stick, leading to unreliable actuation and a loss of control of the console. Third, the controller may experience instability resulting in start-up failure or an inability to drive the pump. Fourth, a software defect may cause calculator process crashes, leading to negative Central Venous Pressure values in Pulmonary Artery Pressure calculations.

The source text does not report any illnesses, injuries, or deaths associated with these defects. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the violative product will cause serious adverse health consequences or death.

The recalled product

Product: Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Manufacturer: Abiomed, Inc.
Category: Medical Device — Cardiac Support
Hazard: loss-of-control
pump-failure
software-defect
Affected units: 179

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: 0042-0010-US
0042-0010-UK
0042-0010-EU
0042-0010-IN
UDI: 00813502010985
00813502010978
00813502010961
00813502011425
Serial No. IC6962
IC7004
IC7036
IC7170
IC7213
IC7214
IC7239
IC7241
IC7677
IC7787
IC7880
IC8105

Distribution

Distributed nationwide across the United States.

Same manufacturer · Abiomed, Inc.

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

Same hazard · loss of control