CLASS II Device recall · Reported 1 May 2019 · FDA Enforcement Report

HeartMate 3 Coring Tool, Sterile EO recalled by Thoratec

Thoratec is recalling HeartMate 3 Coring Tool, Sterile EO, distributed nationwide in the US. The recall was initiated on 1 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled650

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1203-2019
FDA event ID: 82458
Recalling firm: Thoratec, Pleasanton, CA
Classification: Class II
Status: Terminated
Recall initiated: 1 Mar 2019
FDA classified: 19 Apr 2019
Reported: 1 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

1 Mar 2019	Recall initiated by company
19 Apr 2019	Classified by FDA	+49 days
1 May 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide California Georgia Illinois Indiana Louisiana Michigan Minnesota North Carolina New York Ohio Oklahoma South Carolina Texas Utah Washington Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Thoratec

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24 Jun 2026Device	CLASS II	HeartMate HM 11V Li-ion Backup Battery, ABT recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	HeartMate 3" System Controller recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
21 Jan 2026Device	CLASS II	CentriMag Blood Pump recalled by Thoratec	Thoratec	Particulate Matter	Nationwide
26 Nov 2025Device	CLASS II	HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec	Thoratec	Device Malfunction	Nationwide

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