Reported May 1, 2019 · Terminated
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left…
Thoratec Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thoratec Corp. · 6035 Stoneridge Dr · Pleasanton, CA · 94588-3270
Is this the product you have?
- Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular
- Assist System - Product UsageThe 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
- Lot codes and dates
- Lot Numbers
78 of 78 codes
667559466757246675730667792166965696696580669658266965976696601669660467035536703561670356367035676721603672166067216616721663672167167216726721673193496193497193499193501642574064257736449684667559764496806425751642575864257636425768644965764496626512124667792264257566425766642577064496756449681644969166755926677919667792666949186696574193500193502642574564257766449663644966464496796449682644968764496896677924
- Lot Numbers
- Amount recalled
- 650
Where it was sold
Why it was recalled
Small black plastic particle was observed in the left ventricle during implant procedure.
This product could cause temporary or reversible health problems — stop using it.
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