HEARTMATE®, SYSTEM MONITOR TO POWER MODULE CABLE 103859Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813024010753), received between Feb 16, 2021 and Nov 21, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Device Difficult to Setup or Prepare; Electrical Power Problem; Device Difficult to Setup or Prepare; Electrical Power Problem

  IT WAS REPORTED THAT THE CABLE WAS NOT PROVIDING POWER TO THE SYSTEM CONTROLLER. IT WAS LATER CLARIFIED THAT THE BLACK CORD WAS NOT CONNECTING TO THE SYSTEM CONTROLLER. THE MOBILE POWER UNIT AND THE HEARTMATE MONITOR TO POWER MODULAR CABLE WERE EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613899 ↗
• MalfunctionSep 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A SYSTEM MONITOR CABLE WAS NOTED TO BE DAMAGED AT THE END ATTACHED TO THE SYSTEM MONITOR. THE CABLE HAD EXPOSED ELECTRICAL WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428751 ↗
• MalfunctionAug 10, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR TO POWER MODULE CABLE WAS DAMAGED AND THE WIRES WERE EXPOSED NEXT TO THE CONNECTOR. THE SYSTEM MONITOR WAS STILL FULLY FUNCTIONAL, BUT THE HOSPITAL WISHED TO EXCHANGE THE SYSTEM MONITOR TO PREVENT FURTHER TECHNICAL ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203655 ↗
• MalfunctionMay 28, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A DAMAGED SYSTEM MONITOR DATA CABLE RETURNED BECAUSE THE COATING OF THE CABLE WAS DAMAGED AT THE CONNECTOR SITE. THE SYSTEM MONITOR DATA CABLE WAS EXCHANGED THOUGH ITS COMMUNICATION WITH THE SYSTEM MONITOR HAD WORKED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900005 ↗
• MalfunctionFeb 16, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR WAS TAKEN OUT OF SERVICE AS IT WOULD NOT TURN ON. IT WAS NOTED THAT THE SYSTEM MONITOR TO POWER MODULE CABLE WAS FRAYED. UPON EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE CABLE HAD EXPOSED INTERNAL WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333266 ↗