No image published for this recall

No image published for this recall

Datascope MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 - safety alert

Official notice

3 May 2023

Last checked

3 May 2023

Medium riskFDA

An official FDA notice concerns Datascope MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 - safety alert. An official FDA notice concerns MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-05-03. Recall numbers: Z-1462-2023. Check the official notice for the complete list. Published 2023-05-03.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

54

Recall number

Z-1462-2023

Official notice

2023-05-03

The hazard

An official FDA notice concerns MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-05-03. Recall numbers: Z-1462-2023. Check the official notice for the complete list.

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 10607567111117

Event Ids

92021

Recall Numbers

Z-1462-2023

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Affected products

Product 1

MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

Units affected

54

Risk / hazard

An official FDA notice concerns MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-05-03. Recall numbers: Z-1462-2023. Check the official notice for the complete list.

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 · NJ · Mahwah

Affected area 1

US · United States · NJ · Mahwah

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Datascope. Contact: Datascope Corp..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-1462-2023

Event id

92021

Units affected

54

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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