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Heartmate III LVAS Implant Kit
- Starting date:
- June 7, 2017
- Posting date:
- July 6, 2017
- 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-63836
Reason
Abbott is aware of limited reports of errors in communication between the system controller and pump of the Heartmate 3 Left Ventricular Assist System (LVAS). To date, there have been no patient effects related to this situation, however there are frequent advisory alarms that need to be silenced.
Affected products
Heartmate III LVAS Implant Kit
Lot or serial number
Not Applicable
Model or catalog number
106524
Companies
- Manufacturer
-
Thoratec Corporation
6035 STONERIDGE DRIVE
Pleasanton
94588
California
UNITED STATES