Health product recall

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