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Abiomed purge cassette generation 1 for impella

Official notice

4 Mar 2026

HighHealth Canada

An official Health Canada notice concerns Abiomed purge cassette generation 1 for impella. Abiomed, Inc. Has issued a voluntary device recall (removal) of Purge Cassette (Generation 1) due to an increased risk of purge leaks. An updated Purge Cassette (Generation 2) has been developed with a lower risk of purge leaks. Abiomed is coordinating the product removal and replacement process. In the interim, when using a Generation 1 Purge Cassette Abiomed advises closely monitoring the Purge System and consulting the IFU should a 'Purge Pressure Low' alarm occur. Published 2026-03-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81683

Official notice

2026-03-04

The hazard

Abiomed, Inc. Has issued a voluntary device recall (removal) of Purge Cassette (Generation 1) due to an increased risk of purge leaks. An updated Purge Cassette (Generation 2) has been developed with a lower risk of purge leaks. Abiomed is coordinating the product removal and replacement process. In the interim, when using a Generation 1 Purge Cassette Abiomed advises closely monitoring the Purge System and consulting the IFU should a 'Purge Pressure Low' alarm occur.

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.

Skus

0043-0003, 0048-0044, 0550-0004

Other

RA RA-81683

Model Numbers

0043-0003, 0048-0044, 0550-0004

Recall Numbers

81683

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0043-0003

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0048-0044

Product 3

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0550-0004

Risk / hazard

Abiomed, Inc. Has issued a voluntary device recall (removal) of Purge Cassette (Generation 1) due to an increased risk of purge leaks. An updated Purge Cassette (Generation 2) has been developed with a lower risk of purge leaks. Abiomed is coordinating the product removal and replacement process. In the interim, when using a Generation 1 Purge Cassette Abiomed advises closely monitoring the Purge System and consulting the IFU should a 'Purge Pressure Low' alarm occur.

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

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Abiomed.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

81683

Classification

Type I

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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