Reported Jun 19, 2024 · Ongoing
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386,…
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 System Monitor
- REF1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
- Lot codes and dates
- UDI-DI
0081302401014200813024010852. All Serial Numbers
- UDI-DI
- Amount recalled
- 4,842
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected
Using this product could cause serious injury, illness or death — stop using it now.
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