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Impella cp with smartassist and impella 5.5 with smartassist

Official notice

5 Sept 2024

HighHealth Canada

An official Health Canada notice concerns Impella cp with smartassist and impella 5.5 with smartassist. Abiomed has determined there is a risk of optical sensor damage in Impella products when used concurrently and in close proximity with shockwave coronary intra-vascular lithotripsy catheter. Recall Start Date: September 3, 2024 Published 2024-09-05.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76002

Official notice

2024-09-05

The hazard

Abiomed has determined there is a risk of optical sensor damage in Impella products when used concurrently and in close proximity with shockwave coronary intra-vascular lithotripsy catheter. Recall Start Date: September 3, 2024

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

76002

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Affected products

Product 1

Affected products - Impella CP With SmartAssist, Lot or serial number - All lots., Model or catalog number - 0048-0044

Product 2

Affected products - Impella 5.5 With SmartAssist, Lot or serial number - All lots., Model or catalog number - 0550-0004

Risk / hazard

Abiomed has determined there is a risk of optical sensor damage in Impella products when used concurrently and in close proximity with shockwave coronary intra-vascular lithotripsy catheter. Recall Start Date: September 3, 2024

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 With Smartassist And Impella 5.5 With Smartassist.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

76002

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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