Recall image placeholder

No image published for this recall

Abiomed purge cassette generation 1 for impella

Official notice

4 Mar 2026

Last checked

4 Mar 2026

High riskHealth Canada
Watch Abiomed

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

Skus

0043-0003, 0048-0044, 0550-0004

Other

RA RA-81683

Model Numbers

0043-0003, 0048-0044, 0550-0004

Recall Numbers

81683

Checked manually this time?

The app watches your VIN and alerts you automatically next time — no searching, no checking back.

Turn on automatic VIN checks

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 vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Abiomed

Manufacturer

Not provided

Phone

Not provided

Brand: Abiomed.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

81683

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
Something wrong on this page?

Related recalls

CA
Recall image placeholder

Abiomed introducer kits with impella heart pumps

High riskHealth Canada29 Jun 2026
CA
Recall image placeholder

Impella controller

Critical riskHealth Canada13 May 2026
CA
Recall image placeholder

Automated impella® controller

Critical riskHealth Canada28 Apr 2026
CA
Recall image placeholder

Automated impella controller

High riskHealth Canada25 Feb 2026
CA
Recall image placeholder

Automated impella® controller

Medium riskHealth Canada23 Oct 2025
CA
Recall image placeholder

Impella controller

Critical riskHealth Canada18 Sept 2025
CA
Recall image placeholder

Impella® controller

High riskHealth Canada9 Jul 2025
CA
Recall image placeholder

Impella® controller

Critical riskHealth Canada29 Aug 2025
CA
Recall image placeholder

Impella cp with smartassist and impella 5.5 with smartassist

High riskHealth Canada5 Sept 2024
CA
Recall image placeholder

Impella systems

High riskHealth Canada6 Mar 2024
CA
Recall image placeholder

Impella cp

High riskHealth Canada20 Mar 2024
CA
Recall image placeholder

Impella products

Medium riskHealth Canada12 Mar 2024

Weekly recall digest

Get next week's recalls before you need them.

One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.

The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.

This recall was published 4 Mar 2026. The next one won't wait for you to search.

RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.