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.
FDA Recall Z-1203-2019 · Posted 2019-04-19
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Recalling FirmThoratec Corp.
Recall StatusTerminated
Product CodeDSQ
Date Initiated2019-03-01
Date Terminated2022-08-10
Product Quantity650
Reason for Recall
Small black plastic particle was observed in the left ventricle during implant procedure.
Firm Action
On 03/01/19, sales representatives started visiting and telephoning consignees informing them to quarantine affected devices. The firm requested that consignees complete and return the Device Retrieval Template.
On 03/08/19, Urgent Medical Device Recall notices were hand delivered to all impacted accounts. Customers were advised to stop use, quarantine, and return any units on hand. For patients, who's implant procedure included the use of affected devices, firm recommends close vigilance for potential harm, which could include concerns such as infection or thromboembolism. The coring knife is not impacted. Firm requests that customers complete and return the acknowledgement form.
Firm recommends that customer with additional questions call 1-800-456-1477.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of MN, WI, TX, NC, GA, OK, UT, NY, SC, IL, LA, MI, IN, CA, OH, WA. Foreign (OUS): AUSTRIA, BELGIUM, CANADA, ESTONIA, FRANCE, GERMANY, GREECE, INDIA, ITALY, KUWAIT, LIECHTENSTEIN, LITHUANIA, NETHERLANDS, POLAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TURKEY, UNITED KINGDOM
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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