Public recall detail

Abiomed Purge Cassette Generation 1 for Impella

2026-03-04

medium
General hospital and personal use - Cardiovascular Performance
Quick summary

Quick summary: Abiomed Purge Cassette Generation 1 for Impella. Reason: Performance. Category: General hospital and personal use - Cardiovascular. Date: 2026-03-04.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Abiomed Purge Cassette Generation 1 for Impella. Reason: Performance. Category: General hospital and personal use - Cardiovascular. Date: 2026-03-04.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAbiomed Inc.
ProductAbiomed Purge Cassette Generation 1 for Impella
IssueMedical devices - Performance
Recall classType I
IdentificationRA-81683

Affected products

ProductPurge Cassette, 5 Pack
LotMore than 10 numbers, contact manufacturer.
Model0043-0003
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPurge Cassette, 5 Pack
ProductImpella CP Smart Assist Set (includes Generation 1 Purge Cassette)
LotMore than 10 numbers, contact manufacturer.
Model0048-0044
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionImpella CP Smart Assist Set (includes Generation 1 Purge Cassette)
ProductImpella 5.5 With SmartAssist Set (includes Generation 1 Purge Cassette)
LotMore than 10 numbers, contact manufacturer.
Model0550-0004
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionImpella 5.5 With SmartAssist Set (includes Generation 1 Purge Cassette)

Issue

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use Health products - Medical devices - Cardiovascular
CompaniesAbiomed Inc. 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
Recall date2026-03-06
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-81683
Background{}
CompaniesAbiomed Inc. 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
AudiencesHealthcare
Source updated2026-03-04

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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