Reported May 8, 2024 · Ongoing

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, 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
  • REF106524US, Sterile EO, RxOnly
Lot codes and dates
  • UDI00813024013297/Serial
  • Number

    882 of 882 codes

    • MLP-026628
    • MLP-026733
    • MLP-026929
    • MLP-027005
    • MLP-027322
    • MLP-027363
    • MLP-027387
    • MLP-027390
    • MLP-027596
    • MLP-027678
    • MLP-027879
    • MLP-028290
    • MLP-028518
    • MLP-028665
    • MLP-028754
    • MLP-028931
    • MLP-029026
    • MLP-029108
    • MLP-029187
    • MLP-029304
    • MLP-029368
    • MLP-029462
    • MLP-029473
    • MLP-029656
    • MLP-029682
    • MLP-029686
    • MLP-029845
    • MLP-030174
    • MLP-030180
    • MLP-030215
    • MLP-030216
    • MLP-030844
    • MLP-030945
    • MLP-030993
    • MLP-031350
    • MLP-031430
    • MLP-031507
    • MLP-031529
    • MLP-031710
    • MLP-031725
    • MLP-031780
    • MLP-032045
    • MLP-032092
    • MLP-032194
    • MLP-032302
    • MLP-032534
    • MLP-032794
    • MLP-032917
    • MLP-032926
    • MLP-032952
    • MLP-033026
    • MLP-033232
    • MLP-033394
    • MLP-033541
    • MLP-033633
    • MLP-033799
    • MLP-033829
    • MLP-033875
    • MLP-033905
    • MLP-033948
Amount recalled
882 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.