This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (2015-09-14)
- Starting date:
- September 14, 2015
- Posting date:
- October 5, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55228
Affected Products
- HeartMate II LVAS Implant Kit
- HeartMate II System Controller
Reason
Failure of hospitals to properly monitor the expiration date of the 11V Lithium Ion backup battery ("backup battery") in the HeartMate II LVAS System Controller can result in preventable back up battery advisory alarms and unwarranted system controller exchanges by patients. These mishaps could potentially lead to patient injury or death.
Affected products
A. HeartMate II LVAS Implant Kit
Lot or serial number
All lots.
Model or catalog number
- 106015
- 107801
Companies
- Manufacturer
-
Thoratec Corporation
6035 STONERIDGE DRIVE
Pleasanton
94588
California
UNITED STATES
B. HeartMate II System Controller
Lot or serial number
All lots.
Model or catalog number
- 106762
Companies
- Manufacturer
-
Thoratec Corporation
6035 STONERIDGE DRIVE
Pleasanton
94588
California
UNITED STATES