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HEARTWARE VENTRICULAR ASSIST SYSTEM HVAD - IMPLANT KIT
- Starting date:
- August 22, 2016
- 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-60080
Affected Products
HEARTWARE VENTRICULAR ASSIST SYSTEM HVAD - IMPLANT KIT
Reason
Bio-Rad is conducting a recall for specified implant kits (pumps) in hospital inventory which may be more susceptible to electrical faults if the driveline becomes contaminated.
Affected products
HEARTWARE VENTRICULAR ASSIST SYSTEM HVAD - IMPLANT KIT
Lot or serial number
All lots prior to HW25838.
Model or catalog number
1104
Companies
- Manufacturer
-
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES