HeartMate II, System ControllerRecalls & reported problems across all models

We found 2 models of HeartMate II, System Controller by Thoratec Corporation in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Sep 24, 2020 and Apr 23, 2024 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Electrical Power Problem” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HeartMate II, System Controller problems

HeartMate II, System Controller models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HeartMate II®, System Controller 10005080

  Ventricular (Assisst) Bypass
  24 reports
• HeartMate II®, System Controller 105109

  Ventricular (Assisst) Bypass
  1 report

Recent HeartMate II, System Controller adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CONTROLLER EXCHANGE DUE TO WEAR AND TEAR ON THE CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165367 ↗
• MalfunctionAug 15, 2023Mechanical Problem; Communication or Transmission Problem; Mechanical Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH A TEAR ON THE BLACK POWER CABLE FOR THEIR HEARTMATE II SYSTEM CONTROLLER. UPON HOOKING THE PATIENT UP TO THE MONITOR, THE MONITOR WOULD NOT REGISTER THAT THE CONTROLLER WAS CONNECTED AND THEREFORE THE LOG FILES COULDN'T BE DOWNLOADED. A SECOND MONITOR WAS TRIED WITHOUT SUCCESS. THERE WAS NO DAMAGE NOTED ON THE PATIENT'S WHITE POWER CABLE OR DRIVELINE. THE PATIENT DENIED KNOWING ABOUT ANY DAMAGE TO THE CABLE AND THOUGHT THE DAMAGE HAD OCCURRED DURING THE NIGHT. THE CONTROLLER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550802 ↗
• MalfunctionAug 1, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT PUMP STOPS AND LOW FLOW ALARMS WERE NOTED IN THE LOG FILE HISTORY. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS LISTED FOR URGENT TRANSPLANT, WAS ADMITTED TO THE WARD, AND WAS BEING MONITORED. THE LOG FILE CAPTURED A REPLACE SYSTEM CONTROLLER MESSAGE DUE TO AN LCD FAULT EVENT WHICH SELF-CORRECTED. THE PATIENT WAS TRANSPLANTED ON 29 APR 2023. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4) (PUMP)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437958 ↗
• MalfunctionJul 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S CONTROLLER ALARMED "CALL HOSPITAL CONTACT". THE PATIENT'S WIFE EXCHANGED THE CONTROLLER. THE CONTROLLER EXCHANGE RESOLVED THE ALARM BUT THE PATIENT'S WIFE WAS UNABLE TO TURN OFF THE CONTROLLER WHEN IT WAS NO LONGER IN USE. THE CONTROLLER WOULD NOT RESPOND TO ANY BUTTON BEING PRESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17366622 ↗
• MalfunctionMar 10, 2023Disconnection; Electrical Power Problem; Disconnection; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE LOW VOLTAGE ALARMS. A REVIEW OF THE LOG FILES REVEALED SEVERAL ODD LOW POWER ALARMS WHILE THE PATIENT WAS CONNECTED TO BATTERIES. THE CUSTOMER TRIED CLEANING BATTERIES AND CLIPS AND HAD SENT THE PATIENT NEW CLIPS; THE PATIENT CONTINUED TO GET ALARMS. THE ALARMS RESOLVED AFTER A CONTROLLER EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522820 ↗
• 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 ↗
• MalfunctionSep 30, 2022Break; Mechanical Problem; Device Difficult to Setup or Prepare; Break; Mechanical Problem; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT WHEN ATTEMPTING TO CONNECT THE SYSTEM CONTROLLER TO THE POWER MODULE, THE BLACK POWER CABLE COULD NOT MAKE CONNECTION. UPON CLOSER INSPECTION, THE NURSE NOTED A BROKEN PIN THAT WAS STUCK IN THE CABLE. THE PATIENT REQUIRED A CONTROLLER EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513852 ↗
• MalfunctionAug 3, 2022Electrical Power Problem; Material Deformation; Electrical Power Problem; Material Deformation

  IT WAS REPORTED THAT THE PATIENT HAD MANY LOW VOLTAGE ALARMS AS WELL AS VISIBLE DAMAGE NOTED ON THE BLACK POWER CABLE. THE CONTROLLER WAS EXCHANGED AND NO PLAN FOR RETURNING THE CONTROLLER WAS MADE. THE ALARMS RESOLVED WITH CONTROLLER EXCHANGE AND NO ALARMS WERE HEARD ON THE NEW CONTROLLER. A REVIEW OF THE LOG FILES REVEALED ODD STRINGS OF LOW POWER ADVISORY AND POWER CABLE DISCONNECTS ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15158470 ↗
• MalfunctionJul 7, 2022Disconnection; Mechanical Problem; Electrical Power Problem; Material Deformation; Disconnection; Mechanical Problem; Electrical Power Problem; Material Deformation

  IT WAS REPORTED THAT THE PATIENT HAD SEVERAL POWER CABLE DISCONNECTS AND LOW VOLTAGE ADVISORIES THAT WERE OF UNKNOWN ORIGIN. DAMAGE TO THE BEND RELIEF PORTION OF THE SYSTEM CONTROLLER POWER CABLES WAS ALSO OBSERVED WITH GREEN SLUDGE SHOWING THROUGH. THE SYSTEM CONTROLLER WAS EXCHANGED. LOG FILE ANALYSIS CONFIRMED UNUSUAL POWER CABLE DISCONNECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14948579 ↗
• MalfunctionMar 24, 2022Disconnection; Electrical Power Problem; Disconnection; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD MANY LOW VOLTAGE ALARMS ON THEIR LOG FILE HISTORY. THE BATTERY CLIPS WERE LESS THAN 1 YEAR OLD AND LOOKED CLEAN. THE BATTERIES WERE 3 YEARS OLD. THE BATTERY CLIPS WERE REPLACED AND THE NEW BATTERIES WERE USED WITH THE PATIENT'S OLD BATTERY CLIPS, HOWEVER; THE CONTROLLER POWER IMMEDIATELY DROPPED FROM 4 TO 3 BARS. ANOTHER ATTEMPT WAS MADE USING NEW BATTERIES AND NEW BATTERY CLIPS AND THE POWER REMAINED AT 4 BARS. A REVIEW OF THE LOG FILE REVEALED 3 TRANSIENT LOW VOLTAGE ALARMS. TWO OCCURRED ON (B)(6) 2022 AT 1612 AND ONE OCCURRED ON (B)(6) 2022 AT 1618. ALL WHILE THE PATIENT WAS TETHERED ON BATTERIES. THE PATIENT STATED THEY CONTINUED TO HEAR ALARMS AFTER THE BATTERY AND CLIPS WERE EXCHANGED. A CONTROLLER EXCHANGE WAS PERFORMED ON (B)(6) 2022 AND THE ALARMS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13894774 ↗
• MalfunctionJan 27, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENTS WAVEFORMS WERE SENT FOR REVIEW. THE DATA SHOWED NUMEROUS PUMP STOPS AND LOW SPEED ADVISORIES BETWEEN (B)(6) 2021 AND (B)(6) 2021. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN LOG FILE HISTORY. THERE WAS POTENTIAL CONCERN FOR AN AREA WHERE THE SHIELDING APPEARED TO BE WORN DOWN. ON (B)(6) 2021 THE PATIENT RECEIVED A PUMP EXCHANGE. RELATED MANUFACTURER REPORT NUMBER: 2916596-2021-06285.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366819 ↗
• MalfunctionDec 8, 2021Disconnection; Complete Loss of Power; Disconnection; Complete Loss of Power

  RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2021-06881. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH ALARMS WHILE ON BATTERY POWER. IT APPEARED TO BE NO EXTERNAL POWER, DESPITE PATIENT CLAIMED HE WALKED OUT THE DOOR. UPON EXAMINATION OF THE HISTORY, A PUMP STOP WAS NOTED. THE PATIENT HAD A HISTORY OF SHORT TO SHIELD WITH AN EXTERNAL REPAIR IN (B)(6) 2020. A LOG FILE REVIEW SHOWED A PUMP STOP EVENT ON (B)(6) 2021 AT 07:01AM WHILE ON USING THE POWER MODULE AND THERE WERE NO FURTHER PUMP STOPS IN THE LOG. THERE WERE A FEW LOW VOLTAGE NO EXTERNAL POWER EVENTS ON (B)(6) 2021 AT 12:33, 12:24, AND 12:31 WHILE USING BATTERY POWER AND APPEARED TO BE AN ISSUE WITH THE BATTERY CLIPS/14V BATTERIES. THERE WAS POTENTIALLY A WEAK CONNECTION BETWEEN THE BATTERY CLIPS AND THE POWER LEADS ON THE CONTROLLER. THE DRIVELINE REPAIR IN JULY 2020 WAS SUCCESSFUL AND THE PATIENT WAS ON AN UNGROUNDED CABLE. THERE WAS NOT ENOUGH EVIDENCE TO CALL THIS EVENT A SHORT TO SHIELD BUT THE PATIENT WAS PLANNED TO RETURN IN A COUPLE WEEKS. THE BATTERY CLIPS WOULD BE EXCHANGED TO SEE IF THAT WILL RESOLVE THE LOW VOLTAGE/NO EXTERNAL POWER ISSUES. THE BATTERY CLIPS WERE EXCHANGED AND THE BLACK POWER CORD A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961470 ↗
• InjuryDec 2, 2021Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT HAD A FLASHING RED BATTERY ALARM WITH THE SCREEN DISPLAYING "REPLACE POWER IMMEDIATELY". THE PATIENT REPLACED THEIR BATTERIES TO FULLY CHARGED ONES AND THE ALARMS CONTINUED. AFTER SWITCHING BACK AND FORTH FROM BATTERIES TO THE POWER MODULE, THE ALARMS RESOLVED. THE PATIENT WAS IN THE EMERGENCY ROOM AND ALARMS APPEARED ON THE POWER MODULE. THE PATIENT'S PRIMARY CONTROLLER WAS EXCHANGED AND THE ALARMS RESOLVED IMMEDIATELY. A LOG FILE ANALYSIS CONFIRMED SEVERAL LOW BATTERY HAZARD ALARMS AND NO EXTERNAL POWER ALARMS BETWEEN (B)(6) 2021 AND (B)(6) 2021 BEFORE THE PATIENT'S CONTROLLER WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917444 ↗
• MalfunctionNov 2, 2021Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD RANDOM BEEPING LOW VOLTAGE ALARMS, DESPITE CLEANING CLIPS/CONNECTIONS AND SWAPPING TO NEW EQUIPMENT. THE SYSTEM CONTROLLER WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738014 ↗
• MalfunctionNov 1, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM CONTROLLER WAS HOT. THEY HAD A CONTROLLER EXCHANGE ON (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12733074 ↗

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