Heartmate 3 LVAS Implant Kit (2018-05-29)
- Starting date:
- May 29, 2018
- Posting date:
- June 14, 2018
- 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-67030
Affected products
Heartmate 3 LVAS Implant Kit
Reason
Abbott is providing additional information to the letter recently issued associated with HeartMate 3 (HM3) outflow graft twist occlusions. On April 5th, 2018 Abbott issued a medical device advisory regarding the heartmate 3 left ventricular assist system and reports of outflow graft twist occlusions with a low incidence rate (0.72%). This current communication provides further clarification on the origin of the outflow graft twist, the persistent low flow alarm, additional recommendations for patient management, and future mitigations that will be implemented.
Affected products
Heartmate 3 LVAS Implant Kit
Lot or serial number
Not applicable
Model or catalog number
106524US
Companies
- Manufacturer
-
Thoratec Corporation
6035 STONERIDGE DRIVE
Pleasanton
94588
California
UNITED STATES