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