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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82458

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 01, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Thoratec Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1203-2019
Recall number
Z-1203-2019
Initiated
March 01, 2019
Classification
Class II
Status
Terminated
Recalling firm
Thoratec Corp.
Quantity
650

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
plastic particle

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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

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