Public recall detail

Impella Systems

2024-03-06

medium
Recall Safety notice
Quick summary

Quick summary: Impella Systems. Date: 2024-03-06.

Recommended action

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

Recall details

Quick summary: Impella Systems. Date: 2024-03-06.

Official details

Affected product details

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

BrandAbiomed Inc.
ProductImpella Systems
IssueMedical devices - Labelling and packaging
Recall classType I
IdentificationRA-75182

Affected products

ProductImpella 5.0
LotAll lots.
Model005064
Serial numberAll lots.
DescriptionImpella 5.0
ProductImpella 5.5 With Smart Assist
LotAll lots.
Model0550-0004
Serial numberAll lots.
DescriptionImpella 5.5 With Smart Assist
ProductImpella Cp
LotAll lots.
Model0048-0004
Serial numberAll lots.
DescriptionImpella Cp
ProductImpella Cp With Smart Assist
LotAll lots.
Model0048-0044
Serial numberAll lots.
DescriptionImpella Cp With Smart Assist

Issue

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesAbiomed Inc. 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-75182
Background{}
CompaniesAbiomed Inc. 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
AudiencesHealthcare
Source updated2024-03-06

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

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