Reported Jan 8, 2020 · Terminated
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when…
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?
HeartMate 3 Mobile Power UnitREF 107754
- UDI or GTIN
00813024010883and 107758
- UDI or GTIN00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US
- UDI or GTIN
00813024013297and 106524
- UDI or GTIN00813024011712 -
- Product UsageProvides power to the System Controller and pump. - Provides power to the System Monitor when it is connected to the Power Module. - Connects the System Monitor to the System Controller for monitoring purposes. - Echoes System Controller alarms. The Mobile Power Unit is for home or clinical use when the patient does not require monitoring using the System Monitor. The Mobile Power Unit is used when the patient is indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable. The cable transfers power from the Mobile Power Unit to the System Controller
- Lot codes and dates
- All serial numbers.
- Amount recalled
- 13871
Where it was sold
Why it was recalled
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
This product could cause temporary or reversible health problems — stop using it.
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