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Abiomed - safety alert

Official notice

15 Oct 2025

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 2025-10-15. Recall numbers: Z-0069-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

10,153

Recall number

Z-0069-2026

Official notice

2025-10-15

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.

Event Ids

97617

Recall Numbers

Z-0069-2026

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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

CO · Colombia

Affected area 10

CZ · Czech Republic

Affected area 11

DE · Germany

Affected area 12

DK · Denmark

Affected area 13

ES · Spain

Affected area 14

FI · Finland

Affected area 15

FR · France

Affected area 16

GB · United Kingdom

Affected area 17

GR · Greece

Affected area 18

HK · Hong Kong

Affected area 19

HR · Croatia

Affected area 20

IE · Ireland

Affected area 21

IL · Israel

Affected area 22

IN · India

Affected area 23

IT · Italy

Affected area 24

JP · Japan

Affected area 25

KW · Kuwait

Affected area 26

LU · Luxembourg

Affected area 27

MX · Mexico

Affected area 28

MY · Malaysia

Affected area 29

NL · Netherlands

Affected area 30

NO · Norway

Affected area 31

NZ · New Zealand

Affected area 32

PK · Pakistan

Affected area 33

PL · Poland

Affected area 34

RS · Serbia

Affected area 35

SA · Saudi Arabia

Affected area 36

SE · Sweden

Affected area 37

SG · Singapore

Affected area 38

SI · Slovenia

Affected area 39

TH · Thailand

Affected area 40

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-0069-2026

Event id

97617

Units affected

10,153

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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