No image published for this recall

No image published for this recall

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly - safety alert

Official notice

8 May 2024

Last checked

8 May 2024

Critical riskFDA

An official FDA notice concerns Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly - safety alert. An official FDA notice concerns Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-05-08. Recall numbers: Z-1692-2024. Check the official notice for the complete list. Published 2024-05-08.

What to do now

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

Units affected

882

Recall number

Z-1692-2024

Official notice

2024-05-08

The hazard

An official FDA notice concerns Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-05-08. Recall numbers: Z-1692-2024. 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

94232

Recall Numbers

Z-1692-2024

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Affected products

Product 1

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

Units affected

882

Risk / hazard

An official FDA notice concerns Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-05-08. Recall numbers: Z-1692-2024. 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 · CA · Pleasanton

Affected area 1

US · United States · CA · Pleasanton

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Thoratec. Contact: Thoratec Corp..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-1692-2024

Event id

94232

Units affected

882

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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