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