HeartMate 3 Coring Tool (2019-03-06)

Starting date:
March 6, 2019
Posting date:
March 12, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69296

Affected Products

HeartMate 3 Coring Tool

Reason

Abbott received a complaint regarding a piece of black particle identified by the surgeon in the heart chamber following the use of the optional HeartMate 3 Coring Tool in a procedure used to core the left ventricle. Abbott identified that the black particles were plastic shavings from the protective black shipping cap of the coring tool.

Affected products

HeartMate 3 Coring Tool

Lot or serial number

Not applicable.

Model or catalog number

10005872

Companies
Manufacturer
Thoratec Corporation
6035 STONERIDGE DRIVE
Pleasanton
94588
California
UNITED STATES