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HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD IMPLANT KIT (2016-05-09)
- Starting date:
- May 9, 2016
- Posting date:
- May 10, 2016
- 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-58282
Affected products
- HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD IMPLANT KIT
Reason
HeartWare has opened an increased number of complaints for loose connector ports within the controller body. In parallel, there has been an increasing trend of customer reports of loose connectors.
Affected products
-
HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD IMPLANT KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 1470CA
Companies
- Manufacturer
-
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES