Reported May 23, 2018 · Terminated

Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for…

Abbott

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: Abbott · 6035 Stoneridge Dr · Pleasanton, CA · 94588-3270

Is this the product you have?

  • Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
Lot codes and dates
  • United StatesUDI: 00813024013297
  • Serial Numbers

    2,187 of 2,187 codes

    • MLP 000976
    • MLP 000989
    • MLP 000991
    • MLP 000999
    • MLP 001002
    • MLP 002020
    • MLP 002041
    • MLP 002048
    • MLP 002049
    • MLP 002056
    • MLP 002057
    • MLP 002058
    • MLP 002059
    • MLP 002066
    • MLP 002069
    • MLP 002070
    • MLP 002071
    • MLP 002072
    • MLP 002074
    • MLP 002075
    • MLP 002076
    • MLP 002080
    • MLP 002082
    • MLP 002084
    • MLP 002087
    • MLP 002088
    • MLP 002090
    • MLP 002091
    • MLP 002093
    • MLP 002096
    • MLP 002117
    • MLP 002118
    • MLP 002119
    • MLP 002120
    • MLP 002121
    • MLP 002123
    • MLP 002124
    • MLP 002125
    • MLP 002126
    • MLP 002127
    • MLP 002128
    • MLP 002130
    • MLP 002132
    • MLP 002133
    • MLP 002134
    • MLP 002135
    • MLP 002136
    • MLP 002137
    • MLP 002141
    • MLP 002144
    • MLP 002152
    • MLP 002155
    • MLP 002156
    • MLP 002157
    • MLP 002158
    • MLP 002159
    • MLP 002160
    • MLP 002162
    • MLP 002163
    • MLP 002161
Amount recalled
5,607

Where it was sold

Why it was recalled

Stop using this product now

Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 15, 2021 · Data as of Sep 19, 6:15 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.