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Abiomed - safety alert

Official notice

24 May 2023

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 2023-05-24. Recall numbers: Z-1590-2023. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

610

Recall number

Z-1590-2023

Official notice

2023-05-24

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

91955

Recall Numbers

Z-1590-2023

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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

AT · Austria

Affected area 3

CH · Switzerland

Affected area 4

DE · Germany

Affected area 5

ES · Spain

Affected area 6

FR · France

Affected area 7

GB · United Kingdom

Affected area 8

HR · Croatia

Affected area 9

IT · Italy

Affected area 10

JP · Japan

Affected area 11

KW · Kuwait

Affected area 12

NO · Norway

Affected area 13

RS · Serbia

Affected area 14

SA · Saudi Arabia

Affected area 15

SI · Slovenia

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-1590-2023

Event id

91955

Units affected

610

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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