HeartMate, 14v Li-Ion Battery (SING) 102515-SINGRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813024012733), received between Dec 31, 2018 and Jul 20, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT SPILLED LIQUID ON THE BATTERY CHARGER, WHICH MADE AN ELECTRIC ZAPPING SOUND AND STARTED TO SMOKE. THE PATIENT THEN USED A SET OF BATTERIES FROM THE CHARGER AND STARTED HAVING FREQUENT LOW VOLTAGE AND POWER CABLE DISCONNECT ALARMS. THE BATTERIES AND CHARGER WERE EXCHANGED AND THE PATIENT HAD NO FURTHER ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197355 ↗
• MalfunctionJan 21, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT'S DEVICE HAD LOW POWER HAZARD ALARMS ON (B)(6) 2021 WHICH CONTRIBUTED TO ADDITIONAL PUMP STOPPAGES. THESE WERE DUE TOTAL DEPLETION OF BATTERY POWER. RELATED MANUFACTURER REPORT NUMBER # 2916596-2021-00046. RELATED MANUFACTURER REPORT NUMBER # 2916596-2021-00054.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11208575 ↗
• MalfunctionDec 31, 2018Power Problem; Power Problem

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT¿S PRIMARY SYSTEM CONTROLLER WAS PRODUCING ALARMS OF RANDOM BEEP WHEN CONNECTED TO ONE SET OF BATTERIES. IT WAS ALSO REPORTED THAT ON AN UNSPECIFIED DATE WHEN DISCONNECTING FROM THE BATTERIES, THE PATIENT FELT ONE OF THE BATTERIES VIBRATE AND THEN RECEIVED AN EXTERNAL ELECTRICAL SHOCK TWICE. THE BATTERIES WERE EXCHANGED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT DUE TO THE EVENT.

  Patient problems: Shock

  MAUDE report 8205661 ↗