Public recall detail

Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems

2024-03-06

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Recall Safety notice
Quick summary

Quick summary: Heartmate II™ and Heartmate 3™ Left Ventricular Assist 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: Heartmate II™ and Heartmate 3™ Left Ventricular Assist 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.

BrandTHORATEC CORPORATION
ProductHeartmate II™ and Heartmate 3™ Left Ventricular Assist Systems
IssueMedical devices - Performance
Recall classType I
IdentificationRA-75183

Affected products

ProductHeartmate II LVAS - Implant Kit
LotMore than 10 numbers, contact manufacturer.
Model103695-CAN 106015
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHeartmate II LVAS - Implant Kit
ProductHeartmate II LVAS - Implant Kit With Sealed Grafts
LotMore than 10 numbers, contact manufacturer.
Model104911
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHeartmate II LVAS - Implant Kit With Sealed Grafts
ProductHeartmate 3 LVAS Implant Kit
LotMore than 10 numbers, contact manufacturer.
Model106524 106524US
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHeartmate 3 LVAS Implant Kit

Issue

Abbott is notifying customers of a planned update to instructions for use associated with observed outflow graft deformation known as "extrinsic outflow graft obstruction" (EOGO) associated with the Heartmate 3™ left ventricular assist system (LVAS) and Heartmate II™ LVAS. Significant EOGO will manifest clinically as as a persistent low flow alarm under certain circumstances in some patients, and in such cases, may impair the ability of the Heartmate LVAS to provide adequate hemodynamic support. Recall start date: February 20, 2024

What you should do

  • Contact the manufacturer if you require additional information .
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesThoratec Corporation 6035 Stoneridge Drive, Pleasanton, California, United States, 94588
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-75183
Background{}
CompaniesThoratec Corporation 6035 Stoneridge Drive, Pleasanton, California, United States, 94588
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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