Recall Z-1203-2019— Thoratec Corp.
Class II · Terminated
Class II FDA medical device recall by Thoratec Corp., initiated 2019-03-01, terminated 2022-08-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.. Reason: Small black plastic particle was observed in the left ventricle during implant procedure..
- Recalling firm
- Thoratec Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-01
- Terminated
- 2022-08-10
- Firm location
- Pleasanton, CA, United States
Product description
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
Reason for recall
Small black plastic particle was observed in the left ventricle during implant procedure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.