No image published for this recall

No image published for this recall

Datascope Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 - safety alert

Official notice

6 Sept 2023

Last checked

6 Sept 2023

Medium riskFDA

An official FDA notice concerns Datascope Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 - safety alert. An official FDA notice concerns Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-09-06. Recall numbers: Z-2487-2023. Check the official notice for the complete list. Published 2023-09-06.

What to do now

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

Units affected

9,379

Recall number

Z-2487-2023

Official notice

2023-09-06

The hazard

An official FDA notice concerns Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-09-06. Recall numbers: Z-2487-2023. 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.

Event Ids

92489

Recall Numbers

Z-2487-2023

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Affected products

Product 1

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Units affected

9,379

Risk / hazard

An official FDA notice concerns Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-09-06. Recall numbers: Z-2487-2023. 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-2487-2023

Event id

92489

Units affected

9,379

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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