Health product recall

HeartMate 3 Sealed Outflow Graft with bend relief (2019-03-31)

Starting date:
March 31, 2019
Posting date:
April 12, 2019
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-69546

Last updated: 2019-04-12

Affected Products

HeartMate 3 Sealed Outflow Graft with bend relief

Reason

There have been reports globally that the HeartMate 3 Outflow Graft exhibited a disconnected screw ring or did not tighten completely and leaked during preparation or implant. The c-ring within the Outflow Graft assembly may not have properly seated during manufacturing. If it is insufficiently seated, it would render the device nonfunctional and would leak during an implant procedure.

Affected products

HeartMate 3 Sealed Outflow Graft with bend relief

Lot or serial number

Not applicable.

Model or catalog number

105581US

Companies
Manufacturer

Thoratec Corporation

6035 STONERIDGE DRIVE

Pleasanton

94588

California

UNITED STATES