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HeartMate III LVAS Implant Kit
- Starting date:
- May 19, 2017
- Posting date:
- June 13, 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-63616
Reason
Abbott has observed cases in which the outflow graft bend relief (OGBR) on the HeartMate 3 (HM3) left ventricular assist system (LVAS) was not fully and evenly secured to the outflow graft. As a result, we conducted an internal review of x-rays from both the U.S. Momentum 3 ide and continuous access protocol (CAP) studies, and identified additional cases where the OGBR was not properly secured.
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