HeartMate II®, System Controller 105109Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813024012528), received between Nov 1, 2022 and Nov 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical Power Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2022Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT'S LOG FILE CAPTURED SEVERAL ODD LOW POWER ALARMS WHEN CONNECTED TO BATTERIES. IT WAS REQUESTED THAT THE BATTERIES AND BATTERY CLIPS BE CHECKED FOR INTEGRITY AND CLEANED WITH AN ALCOHOL WIPE. THE LOG FILE ALSO NOTED A FEW UNSUSTAINED PUMP POWER/ PUMP FLOW ELEVATIONS BETWEEN 04OCT2022 AND 06OCT2022.THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE EQUIPMENT WAS OPERATING AS INTENDED. THE PATIENT'S SYSTEM CONTROLLER WAS EXCHANGED DUE TO A LOW BATTERY ALARM WHILE CONNECTED TO BATTERIES WITH 3 BARS OF CHARGE. THE PATIENT STATED THAT THE BATTERIES HAVE BEEN CALIBRATED RECENTLY AND THEIR BATTERY CLIPS WERE IN GOOD SHAPE VISUALLY. THE ALARMS RESOLVED AFTER THE SYSTEM CONTROLLER EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15711114 ↗