Thoratec HeartMate System Monitor display malfunction in left ventricular assist devices
The Thoratec HeartMate System Monitor is being recalled due to display malfunctions affecting 4,842 devices worldwide. These issues may prevent proper monitoring and device control.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, indicating a device defect that will cause serious adverse health consequences. Per the recall severity rubric, FDA Class I recalls have a minimum severity score of 4 (Severe).
Plain-English summary
The Thoratec HeartMate System Monitor (including REF 1286 and variants) is being recalled. The recall affects 4,842 units distributed worldwide, including the United States, Puerto Rico, and numerous other countries.
The system monitor display screen may exhibit atypical behavior, including overlapping screens and buttons, frozen screens, distorted or missing text, blank values or zero values instead of correct readings, and unresponsive buttons. When buttons are unresponsive, users cannot initiate commands. These issues may lead to anxiety and inconvenience, hemodynamic compromise, extended surgical time, and unintended selection of the pump stop command.
The recalled product
- Product
- Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
- Manufacturer
- Thoratec Corp.
- Hazard
- display-malfunction
- unresponsive-controls
- hemodynamic-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00813024010142
- 00813024010852. All Serial Numbers
Distribution
Distributed nationwide across the United States.
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