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Impella systems

Official notice

6 Mar 2024

Last checked

6 Mar 2024

High riskHealth Canada
Watch Abiomed

An official Health Canada notice concerns Impella systems. IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. Recall start date: February 26, 2024 Published 2024-03-06.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75182

Official notice

2024-03-06

The hazard

IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. Recall start date: February 26, 2024

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

75182

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Affected products

Product 1

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

Product 2

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

Product 3

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

Product 4

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

Risk / hazard

IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. Recall start date: February 26, 2024

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Abiomed, Impella

Manufacturer

Not provided

Phone

Not provided

Brand: Abiomed, Impella.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

75182

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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