Recall Z-1921-2024— Thoratec Corp.
Class I · Ongoing
Class I FDA medical device recall by Thoratec Corp., initiated 2024-05-08. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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.
- Recalling firm
- Thoratec Corp.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-05-08
- Firm location
- Pleasanton, CA, United States
Product description
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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.