Day

June 7, 2024
07
Jun

FDA Recall: Abbott Issues Correction for HeartMate LVAS System Monitor due to Screen Issues that May Cause Unintentional Pump Stop

June 7, 2024
Company: Abbott Medical Group Date of Enforcement Report: 6/7/2024 Class I 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 Recall Number: Z-1921-2024 REASON: System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in...
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