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Hvad implant kit

Official notice

30 May 2022

Last checked

30 May 2022

Medium riskHealth Canada

An official Health Canada notice concerns Hvad implant kit. Pump thrombosis caused by weld defect that allowed moisture into the center post and corroded the magnets that keep the impeller rotating concentrically. Recall start date: April 26, 2022 Published 2022-05-30.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64201

Official notice

2022-05-30

The hazard

Pump thrombosis caused by weld defect that allowed moisture into the center post and corroded the magnets that keep the impeller rotating concentrically. Recall start date: April 26, 2022

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.

Recall Numbers

64201

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Affected products

Product 1

Affected products - HVAD Implant Kit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 1101 1102 1103 1104 1205 1104CA-CLIN

Risk / hazard

Pump thrombosis caused by weld defect that allowed moisture into the center post and corroded the magnets that keep the impeller rotating concentrically. Recall start date: April 26, 2022

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Heartware, Hvad Implant Kit.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64201

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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