HEARTMATE®, POWER MODULE PATIENT CABLE 12V 2225Recalls & reported problems
Thoratec Corporation · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813024010777), received between Jan 28, 2026 and Jan 28, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2026Electrical Power Problem
IT WAS REPORTED THAT THE LOG FILES WERE SUBMITTED FOR EVALUATION. THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR HAD FEEDBACK THAT ALL ALARMS WERE NOT BEING CAPTURED AND SHOWN ON THE SYSTEM MONITOR. A LOG FILES REVIEW SHOWED DATA FROM (B)(6) 2025 AT 4:21:23 TO (B)(6) 2025 AT 11:01:13. MOST OF THE EVENTS WERE ASSOCIATED WITH A (F56) V_UNABLE_CHARGE_EBB POWER FAULT FLAGS, WHICH WAS DUE TO WORN OR DAMAGED PATIENT CABLE. IT WAS RECOMMENDED THAT THE PATIENT CABLE BE REMOVED AND DISCARDED. IT WAS PROVIDING ABOUT 12.5 VOLTS TO THE SYSTEM CONTROLLER. THIS WAS NOT ENOUGH VOLTAGE FOR THE SYSTEM CONTROLLER TO OPERATE THE CHARGING CIRCUITRY FOR THE EMERGENCY BACKUP BATTERY (EBB). MOTOR FUNCTION WAS NOT AFFECTED BY THESE EVENTS. THE POWER FAULT FLAGS WERE RECORDABLE EVENTS BUT NOT ALARMS. THE ALARM HISTORY ON THE SYSTEM MONITOR WOULD NOT SHOW THESE EVENTS. THESE EVENTS WERE OCCURRING FREQUENTLY AND WAS QUICKLY FILLING UP THE LOG FILE HISTORY. THE LATEST LOG FILES WERE PROVIDED. THE PATIENT CABLE WAS EXCHANGED. THE EVENT AND PERIODIC LOGS WERE ABLE TO BE SEEN AND TALLIED ACCORDINGLY. THE LOG FILES SHOWED THE PATIENT CABLE STILL DELIVERING LESS THAN 13.5 VOLTS. THIS NUMBER SHOULD BE 14.5 V FOR A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24201412 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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