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