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Heartware Implant Kit (2015-05-04)
- Starting date:
- May 4, 2015
- Posting date:
- May 21, 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-53411
Recalled Products
A. Heartware Implant Kit
Reason
The manufacturer provides instructions to the clinicians/patients regarding the power management system and the driveline in order to help reduce the occurrence of avoidable injuries as patients remain on the device for increasingly long period of time.
Affected products
A. Heartware Implant Kit
Lot or serial number
All lots.
Model or catalog number
1104XX
Companies
- Manufacturer
-
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES