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U.S. Department of Health and Human Services

Class 2 Device Recall HeartMate 3 Coring Tool

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 Class 2 Device Recall HeartMate 3 Coring Toolsee related information
Date Initiated by FirmMarch 01, 2019
Date PostedApril 19, 2019
Recall Status1 Terminated 3 on August 10, 2022
Recall NumberZ-1203-2019
Recall Event ID 82458
PMA NumberP160054S005 
Product Classification Ventricular (assist) bypass - Product Code DSQ
ProductThoratec 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.
Code Information Lot Numbers: 6675594  6675724  6675730  6677921  6696569  6696580  6696582  6696597  6696601  6696604  6703553  6703561  6703563  6703567  6721603  6721660  6721661  6721663  6721671  6721672  6721673  193496  193497  193499  193501  6425740  6425773  6449684  6675597  6449680  6425751  6425758  6425763  6425768  6449657  6449662  6512124  6677922  6425756  6425766  6425770  6449675  6449681  6449691  6675592  6677919  6677926  6694918  6696574  193500  193502  6425745  6425776  6449663  6449664  6449679  6449682  6449687  6449689  6677924  6677927  6692906  6693957  6696589  193495  193498  6449692  6675591  6675596  6692904  6696599  6512126  6675732  6675734  6675736  6692897  6449677  6692877 
Recalling Firm/
Manufacturer
Thoratec Corp.
6035 Stoneridge Dr
Pleasanton CA 94588-3270
For Additional Information ContactJustin Paquette
651-756-6293
Manufacturer Reason
for Recall
Small black plastic particle was observed in the left ventricle during implant procedure.
FDA Determined
Cause 2
Device Design
ActionOn 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.
Quantity in Commerce650
DistributionUS 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
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = DSQ
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