Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left

FDA device recall Z-1203-2019 · posted 2019-04-19 · Terminated

Recall details

Recalling firm

Thoratec Corp.

Reason for recall

Small black plastic particle was observed in the left ventricle during implant procedure.

Action taken

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

Status

Terminated

Product code

DSQ

Quantity affected

650

Distribution

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, KUW

Date initiated

2019-03-01

Date posted

2019-04-19

Date terminated

2022-08-10

Location

Pleasanton, CA