Reported May 8, 2024 · Ongoing
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
Thoratec Corp.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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, LVAS Implant Kit
- REF106524INT, Sterile EO, RxOnly
- Lot codes and dates
- UDI00813024011712/Serial
- Number
722 of 722 codes
MLP-026628MLP-026733MLP-026929MLP-027005MLP-027322MLP-027363MLP-027387MLP-027390MLP-027596MLP-027678MLP-027879MLP-028290MLP-028518MLP-028665MLP-028754MLP-028931MLP-029026MLP-029108MLP-029187MLP-029304MLP-029368MLP-029462MLP-029473MLP-029656MLP-029682MLP-029686MLP-029845MLP-030174MLP-030180MLP-030215MLP-030216MLP-030844MLP-030945MLP-030993MLP-031350MLP-031430MLP-031507MLP-031529MLP-031710MLP-031725MLP-031780MLP-032045MLP-032092MLP-032194MLP-032302MLP-032534MLP-032794MLP-032917MLP-032926MLP-032952MLP-033026MLP-033232MLP-033394MLP-033541MLP-033633MLP-033799MLP-033829MLP-033875MLP-033905MLP-033948
- Amount recalled
- 659 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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