THORATEC HEARTMATE, SYSTEM MONITORRecalls & reported problems across all models

We found 2 models of THORATEC HEARTMATE, SYSTEM MONITOR by Thoratec Corporation in the FDA's device registry (GUDID). Together they are named in 415 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2018 and Jan 30, 2026 — classified as 6 injuries, 409 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (277 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

THORATEC HEARTMATE, SYSTEM MONITOR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 8, 2024Class IOpen, Classified

   System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

   Z-1921-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported THORATEC HEARTMATE, SYSTEM MONITOR problems

THORATEC HEARTMATE, SYSTEM MONITOR models

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

• THORATEC® HEARTMATE®, SYSTEM MONITOR 1286

  Ventricular (Assisst) Bypass
  1 recall230 reports
• THORATEC® HEARTMATE®, SYSTEM MONITOR 1286A-US

  Ventricular (Assisst) Bypass
  1 recall185 reports

Recent THORATEC HEARTMATE, SYSTEM MONITOR adverse event reports

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

• MalfunctionJan 30, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT ON (B)(6) 2026 WHILE IN THE INTENSIVE CARE UNIT (ICU) AND USING THE SYSTEM MONITOR, THE DISPLAY DISAPPEARED IN TWO PLACES AND THEN BLACKED OUT AND RESTARTED. THERE WAS NO PROBLEM WITH THE DISPLAY AFTER RESTARTING. NO HEALTH HAZARD OCCURRED TO THE PATIENT. LOG FILE ANALYSIS WAS REQUESTED OUT OF CAUTION FOR THE PATIENT WHO WAS BEING CARED FOR USING THE SYSTEM MONITOR, AND THE LOG FILES CAPTURED NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE PATIENT'S EQUIPMENT WAS OPERATING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223996 ↗
• MalfunctionOct 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THERE WAS A PUMP STOP; 0 FLOW RED ADVISORY ALARM DISPLAYED ON SYSTEM MONITOR BUT FLOW AND SPEED WAS THERE UNDER THE PUMP FLOW. SYSTEM CONTROLLER FLOW AND SPEED WERE ALSO CHECKED WHICH WERE SHOWING. THE SYSTEM MONITOR WAS RESTARTED AND THAT RESOLVED THE ISSUE. THE PATIENT WAS STABLE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT. NO UNUSUAL EVENTS WERE SEEN IN THE LOG FILES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372222 ↗
• MalfunctionOct 17, 2025Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC DUE TO NOTICING THAT THEIR MONITOR SCREEN WAS LIT RED AND CLAIMED THAT THEIR PUMP WAS NOT WORKING AND HAVING LOW FLOWS. THERE WERE NO ALARMS ACTIVE ON THE SYSTEM CONTROLLER AT THE TIME. THE GREEN PUMP RUNNING LIGHT WAS ON AND THE PATIENT WAS SWITCHED TO BATTERIES. THE BEDSIDE NURSE THEN SHUT THE MONITOR DOWN AND TURNED IT BACK ON. WHEN PLACED BACK TO THE POWER MODULE THE MONITOR SCREEN WAS NO LONGER RED. UPON INITIAL INTERROGATION, A LOW VOLTAGE ADVISORY WAS NOTED, BUT NO LOW FLOW ALARMS OR PUMP STOP ALARMS WERE SEEN. LOG FILES WERE SUBMITTED FOR FURTHER REVIEW AND CAPTURED TWO LOW FLOW EVENTS ON 29SEP2025 AT 15:09:29 AND 15:09:33. THE CALCULATED FLOW APPEARED TO HAVE FLUCTUATED BELOW THE ALARM THRESHOLD OF 2.5 LPM DURING THE EVENTS. THE LOG FILE CONTAINED ONLY TWO LOW FLOW ESTIMATES WHEN THE CALCULATED PULSATILITY INDEX WAS DYNAMIC AND ELEVATED. THE LOW FLOW READINGS DID NOT APPEAR TO BE THE RESULT OF ANY EXTERNAL EQUIPMENT MALFUNCTION. THE EVENT LOG FILE DATE RANGE WAS FROM 27SEP2025 TO 30SEP2025, AND NO ADVERSE EVENTS WERE SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325904 ↗
• MalfunctionJul 31, 2025Pumping Stopped; Improper or Incorrect Procedure or Method; Pumping Stopped; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION WAS PROVIDED ON 29JUL2025 THAT THE PUMP STOP WAS UNINTENTIONAL AND DUE TO USER ERROR. THERE WAS NO IMPACT TO PATIENT DUE TO THE PUMP STOP AND THE PATIENT REMAINED IN THE HOSPITAL AND WOULD BE DISCHARGED SOON.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22682514 ↗
• MalfunctionJul 18, 2025Pumping Stopped; Improper or Incorrect Procedure or Method; Pumping Stopped; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED DUE TO PUMP OFF EPISODE. DURING OPERATION, THROMBECTOMY FROM LEFT VENTRICULAR CAVITY WAS DONE, LEFT ATRIAL APPENDAGE (LAA) WAS CLOSED. IN OPERATING ROOM, SYSTEM CONTROLLER WAS PROGRAMMED AS USUAL; BACKUP BATTERY WAS INSTALLED. AFTER TRANSFER TO INTENSIVE CARE UNIT (ICU), APPROXIMATELY 30 MIN LATER, PUMP OFF ALARM SHORTLY APPEARED WITH DROP OF ARTERIAL PRESSURE. IMPLANT TEAM CAME TO THE ICU, AND CHECKED ON PATIENT CONDITION, PUMP, SYSTEM CONTROLLER AND POWER CONNECTIONS. NO TECHNICAL ISSUES WERE NOTED. THE PATIENT REMAINED STABLE. THE LOG FILE CAPTURED ON (B)(6) 2025 AT 13:31:40, INTENTIONAL PUMP STOP MESSAGES (F69). IT APPEARED TO HAVE OCCURRED BY THE SYSTEM MONITOR PUMP STOP COMMAND BEING ACTIVATED. THE PUMP WAS STOPPED FOR ABOUT 2 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542410 ↗
• MalfunctionJul 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) AND THE SYSTEM MONITOR DISPLAYED THE PUMP SPEED AT 21,536 REVOLUTIONS PER MINUTE (RPM). THE SYSTEM CONTROLLER DISPLAYED THE SPEED AT 5,200 RPM. THE SPEED WAS ABLE TO BE CHANGED IN THE SETTING WINDOW OF THE SYSTEM MONITOR, BUT EVEN AFTER THE CHANGE THE SYSTEM MONITOR STILL DISPLAYED THE SPEED AT 21,536 RPM. AFTER LOG FILES WERE DOWNLOADED, THE TOP TAB OF THE SCREEN STOPPED FUNCTIONING, AND THE CLINICAL TAB WAS DISPLAYED IN THE BOTTOM LEFT. THE ISSUE RESOLVED WHEN THE SYSTEM MONITOR WAS RESTARTED. NO PATIENT ADVERSE EVENT OCCURRED DUE TO THIS EVENT. LOG FILE REVIEW SHOWED NO UNUSUAL EVENTS IN THE EVENT LOG FILE HISTORY. THE MECHANICAL CIRCULATORY SUPPORT EQUIPMENT APPEARED TO BE OPERATING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531304 ↗
• MalfunctionJun 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE PATIENT WAS ASYMPTOMATIC. LOG FILES WERE REVIEWED, AND THE EVENT LOG FILE CAPTURED AN INTENTIONAL PUMP STOP ON (B)(6) 2025 AT 14:32:03 CAUSING THE PUMP TO STOP/ THE PUMP RESUMED NORMAL OPERATION AT 14:32:06. THE LOG FILE ALSO CAPTURED INTERMITTENT LOW FLOW ALARMS AND FEW MOMENTARY LOW FLOW ESTIMATES WITH THE CALCULATED PULSATILITY INDEX (PI) ELEVATED STARTING FROM (B)(6) 2025 FROM 21:24 TO 21:48. THERE WERE NO UNUSUAL ROTOR FAULTS, PUMP TEMPERATURE, OR ANY OTHER ABNORMAL PUMP FAULTS WERE SEEN IN THE EVENT LOG. THERE DID NOT APPEAR TO BE ANY TYPE OF EXTERNAL MECHANICAL CIRCULATORY SUPPORT EQUIPMENT ISSUES CAUSING THESE EVENTS. OTHERWISE, THERE WERE NO OTHER NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286007 ↗
• MalfunctionApr 28, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT ON (B)(6) 2025 TWO INSTANCES OF NO EXTERNAL POWER WERE RECORDED, AND ON (B)(6) 2025, A LOW FLOW ALARM AND A PUMP OFF WERE RECORDED. THE PATIENT WAS ASYMPTOMATIC. LOG DISPLAYED LOW FLOW / LVAD OFF / (F69) INTENTIONAL PUMP STOP EVENTS ON (B)(6) 2025 AT ~8:26 AM WHERE IT APPEARED THE INTENTIONAL PUMP STOP COMMAND WAS MOMENTARILY ENABLED AT THE SYSTEM MONITOR. THE PUMP WAS OFF FOR ~1-2 SECONDS. THE LOG FILES DID NOT RECORD ANY NO EXTERNAL POWER ALARMS. 90 PULSATILITY (PI) EVENTS WERE CAPTURED IN THE EVENT LOG. THERE WERE NO OTHER UNUSUAL EVENTS SEEN WITHIN THE LOG FILES. IT WAS UNKNOWN WHY THE PUMP STOP COMMAND WAS INITIATED. THE CAUSE OF THE NO EXTERNAL POWER ALARMS ALSO REMAINED UNKNOWN. NO EQUIPMENT WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919009 ↗
• MalfunctionApr 23, 2025Device Difficult to Setup or Prepare; Pumping Stopped; Device Difficult to Setup or Prepare; Pumping Stopped

  IT WAS REPORTED THAT PATIENT WITH A SENSITIVE MONITOR SCREEN, SEEMED TO HAVE A PUMP STOP EVENT WHILE IN THE INTENSIVE CARE UNIT DURING DEVICE INTERROGATION. THE SYSTEM MONITOR WOULD BE EXCHANGED, EVEN WHEN DOWNLOADING WHEN PRESSING THE LETTERS FOR PATIENT INITIALS MULTIPLE LETTERS WOULD APPEAR. THE LOG FILE CAPTURED ON (B)(6) 2025, AT 10:02:38 AN INTENTIONAL PUMP STOP, WHICH WAS DUE TO THE KEY ON THE SCREEN BEING ACTIVATED. IN ADDITION, IT WAS NOTED ON (B)(6) 2025 LOW SPEED ADVISORIES DUE TO THE FIXED SPEED BEING SET AT 4800 REVOLUTION PER MINUTE (RPM) AND THE LOW-SPEED LIMIT BEING SET TO 5000 RPMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894860 ↗
• MalfunctionMar 31, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR WAS DISPLAYING PREVIOUS SOFTWARE WAS NOT COMPLETED, INSERT SOFTWARE CARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733573 ↗
• MalfunctionMar 19, 2025Display or Visual Feedback Problem; Device Displays Incorrect Message; Display or Visual Feedback Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENTS SYSTEM MONITOR WHILE CONNECTED TO THE SYSTEM CONTROLLER DISPLAYED THAT THE PUMP WAS OFF. THE PATIENT'S CONDITION WAS DESCRIBED AS FINE, AND NO AUDIBLE OR VISUAL ALARMS WERE FOUND. THE CENTER BELIEVED THIS WAS A SYSTEM MONITOR DISPLAY ISSUE. IT WAS RECOMMENDED THAT THE CENTER POWER CYCLE THE SYSTEM MONITOR TO RESOLVE THE ISSUE, AND IF THE ISSUE WERE TO PERSIST, TO TAKE THE SYSTEM MONITOR OUT OF SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646313 ↗
• MalfunctionMar 3, 2025Display or Visual Feedback Problem; Pumping Stopped; Display or Visual Feedback Problem; Pumping Stopped

  IT WAS REPORTED THAT THE PATIENT HAD A LOW FLOW AND PUMP STOP OVERNIGHT. IT WAS UNCLEAR AS TO WHY THIS HAPPENED. THERE WAS INITIAL CONCERN THAT IT WAS DUE TO THE SYSTEM MONITOR. THE EVENT LOG CAPTURED THE PUMP STOP THAT WAS REPORTED ON (B)(6) AT 01:08 WHILE USING THE POWER MODULE. IT APPEARED THAT THE PUMP STOP BUTTON WAS PRESSED ON THE MONITOR THAT RESULTED IN THE BRIEF 2 SECOND PUMP STOP. THE LOG SHOWED "INTENTIONAL PUMP STOP." NO OTHER UNUSUAL EVENTS WERE NOTED IN THE LOG. THE PATIENT'S LEFT VENTRICULAR ASSIST DEVICE (LVAD) CONSOLE SCREEN WAS GLITCHED AND THE CUSTOMER WAS UNABLE TO TOUCH THE SCREEN WITHOUT THE LVAD ALARMING. THE PATIENT SWITCHED TO BATTERY POWER AND WERE STILL FLOWING ON THE SYSTEM CONTROLLER. THE CUSTOMER UNPLUGGED THE CURRENT CONSOLE, BUT IT DID NOT RESOLVE THE ISSUE. THE PATIENT WAS STILL INPATIENT. IT WAS UNKNOWN IF THE SYSTEM MONITOR WAS REBOOTED BEFORE USE. NO PRODUCTS WOULD BE RETURNED. LOG FILES SHOWED THAT THE LOW FLOW ALARMS WERE SECONDARY TO PUMP BEING STOPPED. THE PATIENT HAD NO FURTHER LOW FLOW ALARMS. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF LOW FLOWS. THE PATIENT DID NOT TOUCH ANYTHING ON THE MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21508103 ↗
• MalfunctionFeb 18, 2025Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6)2024 DUE TO WORSENING ARRHYTHMIA SYMPTOMS. THE ARRHYTHMIA WAS CONTROLLED; HOWEVER, THE PATIENT REMAINED HOSPITALIZED AND UNDERWENT FURTHER EXAMINATION AS LOW FLOW WAS LIKELY TO OCCUR. ON (B)(6)2024, SYMPTOMS OF A PULMONARY EMBOLISM WERE NOTED, AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS PERFORMED WHICH WAS NOTED TO BE STILL ONGOING. DURING ECMO MANAGEMENT THE HEARTMATE 3 WAS BARELY WORKING, WITH FLOW BEING 0-0.4 LITERS PER MINUTE AND LOW FLOWS CONSTANTLY ACTIVE. WHEN THE HISTORY WAS CHECKED ON THE SYSTEM MONITOR, IT DISPLAYED "NO RECORDS OBTAINED," SO IT WAS DECIDED TO CHECK WHETHER THE SYSTEM WAS OPERATING NORMALLY. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED LOW FLOW ALARM EVENTS ON (B)(6)2024 THAT OCCURRED AT TIMES WHEN PULSATILITY INDEX (PI) WAS ELEVATED. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED PERSISTENT VENTRICULAR FIBRILLATION REQUIRING DEFIBRILLATION OR CARDIOVERSION ON (B)(6)2024, WAS ADMITTED ON (B)(6)2024 AND HAD A HISTORY OF ARRHYTHMIA PRIOR TO IMPLANT ALONG WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ARRHYTHMIA WAS NOT THOUGHT TO BE DEVICE OR THERAPY REL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396741 ↗
• MalfunctionJan 27, 2025Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT WHEN SWITCHING ON THE SYSTEM MONITOR, THE DISPLAY DID NOT BOOT CORRECTLY. REBOOTING THE SYSTEM MONITOR DID NOT SOLVE THE ISSUE. THE DISPLAY SHOWED EITHER JUST COLORED PIXELS OR BLURRED LINES. THE SYSTEM MONITOR WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240706 ↗
• MalfunctionJan 9, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR SCREEN WOULD FREEZE AT TIMES. THE SYSTEM MONITOR WAS NO LONGER SERVICEABLE AND WAS AN OBSOLETE PRODUCT. THE CUSTOMER PLANNED ON OBTAINING A PATIENT CABLE AND SYSTEM CONTROLLER TO TRY TO DO SOME TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114673 ↗

Other Thoratec Corporation products

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