HeartMate II® Unshielded 14V Patient Cable 10002010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813024011903), received between Mar 5, 2020 and Jul 16, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Mechanical Problem; Mechanical Problem

  DURING EVALUATION OF THE RETURNED SYSTEM CONTROLLER, IT WAS FOUND THAT THE BROKEN PIN HAD COME FROM ANOTHER PIECE OF EQUIPMENT. IT WAS NOTED THAT THE CONTROLLER WAS ONLY CONNECTED TO 14V BATTERIES AND THE POWER MODULE THROUGHOUT THE DOWNLOADED DATA. THE 14V BATTERY CLIP DID NOT HAVE A PIN 5, AND THEREFORE IT WAS SUSPECTED THAT THE BROKEN PIN CAME FROM A POWER MODULE PATIENT CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756718 ↗
• MalfunctionMar 31, 2021Mechanical Problem; Mechanical Problem

  RELATED MFR #: 2916596-2021-01341. IT WAS REPORTED THAT THE PATIENT'S DEVICE ALARMED FOR LOW FLOWS AND ASSOCIATED LOW SPEEDS WERE NOTED. THE PATIENT DESCRIBED NO UNUSUAL POSITION - THEY WERE REPORTEDLY RECLINED IN A CHAIR AT THE TIME. THE EVENTS OCCURRED WHILE THE DEVICE WAS POWERED BY BATTERIES. IT WAS NOTED THAT THE PATIENT HAD UNDERGONE AN EXTERNAL DRIVELINE REPAIR A FEW YEARS AGO. THE LOG FILE CAPTURED 2 LOW SPEED EVENTS AND ONE PUMP STOP AT 22:21 ON (B)(6) 2021. THERE WAS NOT ENOUGH INFORMATION TO DETERMINE A CAUSE FOR THESE EVENTS. THE LOG ALSO CAPTURED 180 PULSATILITY INDEX EVENTS THROUGHOUT THE HISTORY. IT WAS ALSO NOTED THAT THE PATIENT DID NOT CONNECT TO WALL POWER THE PREVIOUS NIGHT, AND SLEEPING ON BATTERY POWER IS NOT RECOMMENDED. THIS WAS REPORTEDLY DUE TO A BROKEN PIN ON THE PATIENT'S UNGROUNDED CABLE NOT ALLOWING THE PATIENT TO CONNECT TO POWER. THE PATIENT CABLE WAS EXCHANGED. THE PATIENT WAS ADMITTED FOR MONITORING. THE PATIENT REPORTED THERE HAD BEEN ANOTHER LOW FLOW EVENT ON (B)(6) 2021 THAT OCCURRED WHILE THEY WERE STANDING. ANOTHER LOG FILE WAS REVIEWED ON(B)(6) 2021 AND REVEALED CONTINUED PI EVENTS, BUT NO FURTHER ALARMS OR DEVICE ISSUES SINCE (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597980 ↗
• MalfunctionSep 21, 2020Pumping Stopped; Material Integrity Problem; Material Twisted/Bent; Pumping Stopped; Material Integrity Problem; Material Twisted/Bent

  THE PUMP WOULD NOT START. THE MONITOR WAS CHANGED AND A KINK IN THE PATIENT CABLE WAS NOTICED. AFTER THE KINK WAS REMOVED, THE PUMP STARTED WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10559915 ↗
• MalfunctionMar 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PINS ON THE INSIDE OF UNGROUNDED PATIENT CABLE BROKE. PATIENT WAS PLACED ON BATTERIES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9794176 ↗