Health product recall

Medtronic HeartWare Ventricular Assist Device (HVAD) System/licence (2021-08-11)

Starting date:
August 11, 2021
Posting date:
August 27, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-76321

Last updated:
2021-08-27

Affected Products 

A. HeartWare Ventricular Assist Device (HVAD) System
B. STERILE HVAD PUMP

Reason

Notification related to HVAD Systems that have undergone a Driveline Strain Relief Repair performed by a Medtronic Field Service Representative. Medtronic internal testing has shown that it may be difficult to pull back the Driveline Cover over a Strain Relief Repair when attempting to access the Driveline Connector. Difficulty in pulling back the Driveline Cover over a Strain Relief repair may cause a delay in accessing the Driveline Connector. This delay may lead to a prolonged pump stop if access to the Driveline Connector is required to address a marginal Driveline connection or change controllers. In addition, pulling back the Driveline Cover over a Driveline Strain Relief Repair may compromise the integrity of the repair. In lab testing, the most common issue observed was the tape that overlaps the end of the Driveline Connector rolled back when pulling the Driveline Cover away from the controller.

Affected products

A. HeartWare Ventricular Assist Device (HVAD) System

Lot or serial number

HW3134

Model or catalog number

1104

Companies
Manufacturer

Heartware Inc.

14400 NW 60th Avenue

Miami Lakes

33014

Florida

UNITED STATES

B. STERILE HVAD PUMP

Lot or serial number

HW1030
HW1592

Model or catalog number

1102

Companies
Manufacturer

Heartware Inc.

14400 NW 60th Avenue

Miami Lakes

33014

Florida

UNITED STATES