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Impella cp

Official notice

20 Mar 2024

HighHealth Canada

An official Health Canada notice concerns Impella cp. There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (tavr) resulting in destruction of the impeller blades. Recall start date: June 20, 2023 Published 2024-03-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73890

Official notice

2024-03-20

The hazard

There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (tavr) resulting in destruction of the impeller blades. Recall start date: June 20, 2023

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

73890

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Affected products

Product 1

Affected products - Impella Cp, Lot or serial number - All lots., `Model or catalogue number - 0048-0004

Product 2

Affected products - Impella Cp With Smart Assist, Lot or serial number - All lots., `Model or catalogue number - 0048-0044

Product 3

Affected products - Impella 5.0, Lot or serial number - All lots., `Model or catalogue number - 005064

Product 4

Affected products - Impella 5.5 with Smart Assist, Lot or serial number - All lots., `Model or catalogue number - 0550-0004

Risk / hazard

There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (tavr) resulting in destruction of the impeller blades. Recall start date: June 20, 2023

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: Abiomed, Impella Cp.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

73890

Classification

Type 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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