No image published for this recall

Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged

Official notice

23 Sept 2026

Last checked

29 Sept 2026

CriticalFDA

An official FDA notice concerns Abiomed. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-09-23. Recall numbers: Z-3149-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,422

Recall number

Z-3149-2026

Official notice

2026-09-23

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

UDI-DI 00813502010930, UDI-DI 00813502010961, UDI-DI 00813502011425, UDI-DI 00813502010978, UDI-DI 00813502010985

Event Ids

99671

Recall Numbers

Z-3149-2026

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AE · United Arab Emirates

Affected area 3

AT · Austria

Affected area 4

AU · Australia

Affected area 5

BE · Belgium

Affected area 6

BR · Brazil

Affected area 7

CA · Canada

Affected area 8

CH · Switzerland

Affected area 9

CL · Chile

Affected area 10

CN · China

Affected area 11

CO · Colombia

Affected area 12

CR · Costa Rica

Affected area 13

CY · Cyprus

Affected area 14

CZ · Czech Republic

Affected area 15

DE · Germany

Affected area 16

DK · Denmark

Affected area 17

ES · Spain

Affected area 18

FI · Finland

Affected area 19

FR · France

Affected area 20

GB · United Kingdom

Affected area 21

GR · Greece

Affected area 22

HK · Hong Kong

Affected area 23

HR · Croatia

Affected area 24

HU · Hungary

Affected area 25

IE · Ireland

Affected area 26

IL · Israel

Affected area 27

IN · India

Affected area 28

IT · Italy

Affected area 29

JP · Japan

Affected area 30

KW · Kuwait

Affected area 31

LU · Luxembourg

Affected area 32

MX · Mexico

Affected area 33

MY · Malaysia

Affected area 34

NL · Netherlands

Affected area 35

NO · Norway

Affected area 36

NZ · New Zealand

Affected area 37

PK · Pakistan

Affected area 38

PL · Poland

Affected area 39

RS · Serbia

Affected area 40

SA · Saudi Arabia

Affected area 41

SE · Sweden

Affected area 42

SG · Singapore

Affected area 43

SI · Slovenia

Affected area 44

TH · Thailand

Affected area 45

TW · Taiwan

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Abiomed. Contact: Abiomed, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class I

App estimate

critical

Recall details

Recall number

Z-3149-2026

Event id

99671

Units affected

1,422

Status

active

Classification

Class I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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