TruClear 7209808Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521749931), received between May 21, 2018 and May 4, 2026 — classified as 6 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (10 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 7, 2022Open, Classified

   Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

   Z-1467-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Failure to Power Up; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN INITIAL STAGE TRANSCERVICAL POLYP RESECTION (TCRP), THE DEVICE CONTROL UNIT WAS UNABLE TO BE ACTIVATED FROM THE BEGINNING OF THE CASE DESPITE SEVERAL ATTEMPTS AND TROUBLESHOOTING. TROUBLESHOOTING EFFORTS INCLUDED SWITCHING CABLES AND PLUGS, AND SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES, BUT THE UNIT STILL FAILED TO POWER ON. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS ALREADY PUT UNDER ANESTHESIA. THEY BORROWED A CONTROL UNIT FROM ANOTHER HOSPITAL AFTER THE CASE BEING ABANDONED TO INVESTIGATE THE CAUSE AND THE NEW UNIT WORKED PERFECTLY FINE.

  Patient problems: Insufficient Information

  MAUDE report 25069809 ↗
• MalfunctionOct 21, 2025Energy Output Problem; Self-Activation or Keying; Energy Output Problem; Self-Activation or Keying

  IT WAS REPORTED THAT DURING TESTING, THE RIGHT FOOT PEDAL WAS UNRESPONSIVE. THE ENGINEER SET UP THE UNIT WITH A HANDPIECE AND OPERATED FORWARDS/BACKWARDS AND OSCILLATE LOCK AT DIFFERENT SPEEDS, THEN KEPT THE FORWARD PEDAL PRESSED WHILE MOVING THE FOOT PEDAL CABLE AND THE HANDPIECE SUDDENLY SPED UP FROM 1000 TO 2500 AND WOULD NOT STOP. THE UNIT HAD TO BE TURNED OFF TO RESET IT. THE ISSUE OCCURRED TWICE BUT WAS VERY INTERMITTENT. THERE WERE NO ERROR CODES DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23348957 ↗
• MalfunctionAug 5, 2025Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CONTROL UNIT HAD AN ERROR 6 THAT WAS WHY THE HANDPIECE/FOOT PEDAL FAILED TO WORK. THEY TRIED PLUGGING IN NUMEROUS HANDPIECES AND CHANGING BLADES BUT THE ISSUE PERSISTED. THEY WERE UNABLE TO COMPLETE THE PROCEDURE AND THE PATIENT WAS ALREADY UNDER ANESTHESIA, THEREFORE, THERE WAS A DELAY TO THE PRESCRIBED TREATMENT FOR THE PATIENT. THE PROCEDURE WAS COMPLETED BY DOING A MANUAL POLYPECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 22714879 ↗
• MalfunctionMar 24, 2025Energy Output Problem; Self-Activation or Keying; Smoking; Device Displays Incorrect Message; Fail-Safe Problem; Energy Output Problem; Self-Activation or Keying; Smoking; Device Displays Incorrect Message; Fail-Safe Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE TRUCLEAR CONTROL UNIT BEGAN TO MALFUNCTION, WITH SMOKE ESCAPING THROUGH THE VENT ON THE RIGHT SIDE OF THE CONTROL UNIT. UPON ACTIVATING THE FOOT PEDAL, THE BLADE WOULD NOT WINDOW LOCK OR ACTIVATE. ADDITIONALLY, THE HANDPIECE BEGAN TO MALFUNCTION, BECAME HOT, AND THE INNER MECHANISM STARTED MOVING WITHOUT ACTIVATION OF THE FOOT PEDAL. THE TRUCLEAR CONTROLUNIT DISPLAYED ERROR CODE 10 DURING SURGERY AND UPON TESTING IT WAS READING ERROR 6. THE CONTROL UNIT WAS TESTED WITH 11 OTHER WORKING HANDPIECES AND STILL WAS NOT WORKING AND WAS SHOWING E6 ERROR CODE. FOOTSWITCH AND BLADE FUNCTIONED PROPERLY ON OTHER WORKING CONTROL UNITS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679156 ↗
• MalfunctionMar 3, 2025Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY AND MYOMECTOMY PROCEDURE, THE DENSE TIS SHAVER PLUS EXPERIENCED A FAILURE OF THE WINDOW LOCK FEATURE AFTER INSERTING THE BLADE INTO THE BACK OF THE SCOPE WHEN IN THE UTERUS. THIS ISSUE LED TO UNANTICIPATED TISSUE LOSS. THE BLADE DID NOT COME PRE-WINDOW LOCKED, AND ATTEMPTS TO LOCK IT WITH THE FOOT PEDAL WERE UNSUCCESSFUL AS IT WOULD FALL OUT OF WINDOW LOCK DURING RESECTION. THERE WAS NO ISSUE WITH HANDPIECE. TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE, SUCTION WAS MANUALLY TURNED ON AND OFF TO ENSURE IT WAS ONLY ACTIVE DURING RESECTION. THE SURGEON CONTINUED TO USE THE DENSE TISSUE SHAVER (DTSP), ALTHOUGH THEY HAD TO MANUALLY TURN ON AND OFF THE SUCTION TO MAINTAIN DISTENTION A VISUALIZATION. NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 21503947 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak

  EVENT DESCRIPTION: DURING A HYSTEROSCOPY WITH A RESECTION OF ASHERMAN'S (SCAR TISSUE BUILDUP), WE HAD SEVERAL ISSUES WITH THE TRUE CLEAR SYSTEM THAT LED TO IT BEING IMPOSSIBLE TO ACCURATELY DETERMINE THE PATIENT'S FLUID DEFICIT. THE SUCTION ON THE TRUE CLEAR SYSTEM ALSO POSSIBLY CONTRIBUTED TO THE PATIENT'S FLUID OVERLOAD DURING SURGERY. THE FLUID OVERLOAD POSSIBLY CONTRIBUTED TO THE SURGEON PERFORATING THE UTERUS, LEADING TO HAVING TO PERFORM AN EMERGENCY DIAGNOSTIC LAPAROSCOPY. THE FLUID OVERLOAD ALSO DIRECTLY RESULTED IN THE PATIENT DEVELOPING PULMONARY EDEMA AFTER THE SURGERY AND REQUIRING LASIX AND A CHEST X-RAY. SPECIFICALLY, PRIOR TO THE SURGERY, WHEN WE WERE SETTING UP AND PRIMING THE TRUE CLEAR SYSTEM, THE SUCTION ON THE RIGHT CANNISTER (THE ONE THAT SUCKS DIRECTLY FROM THE SURGICAL FIELD) WASN'T WORKING. THE SUCTION ON THE LEFT CANNISTER (THE ONE THAT SUCKS FROM THE POUCH) WAS WORKING FINE. WE HAD THE MEDTRONIC REPRESENTATIVE (REP) VERIFY THAT WE HAD SET EVERYTHING UP EXACTLY RIGHT, INCLUDING MAKING SURE THAT A CERTAIN LEVER WAS AT A PERFECT 45 DEGREE ANGLE TO SPLIT THE SUCTION EVENLY BETWEEN THE TWO CANNISTERS. WE DID HAVE EVERYTHING SET UP CORRECTLY. THE REP UNDID ALL O

  Patient problems: Pulmonary Edema

  MAUDE report 20722691 ↗
• MalfunctionSep 5, 2024Intermittent Energy Output; Intermittent Energy Output

  ACCORDING TO THE REPORTER, THE DEVICE POWER SHUTS OFF.

  Patient problems: Insufficient Information

  MAUDE report 20150883 ↗
• MalfunctionSep 5, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, PRIOR TO GYNECOLOGICAL PROCEDURE, THE DEVICE DID NOT WORK WHEN HANDPIECE WAS PLUGGED IN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147765 ↗
• MalfunctionSep 5, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO GYNECOLOGICAL PROCEDURE, THE DEVICE HAD OUT OF BOX FAILURE. THERE WAS NO HANDPIECE POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147761 ↗
• MalfunctionSep 5, 2024Intermittent Energy Output; Intermittent Energy Output

  ACCORDING TO THE REPORTER, PRIOR TO USE, CONTROL UNIT WOULD RUN OKAY WHILE NO SHAVER WAS IN THE HANDPIECE. IT WAS ABLE TO CHANGE BACK AND FORTH MODES AND ADJUST SPEED JUST FINE. IT RAN AS NORMAL WITH SOFT TISSUE SHAVER MINI IN THE HANDPIECE FOR ABOUT A MINUTE BEFORE THEY SWITCHED IN THE DENSE TISSUE SHAVER MINI. IT WAS RUNNING OKAY FOR ABOUT 15-120 SECONDS AND ALL OF A SUDDEN DIED. AT FIRST, IT WAS ONLY THE LEFT PEDAL THAT WASN'T WORKING, THE RIGHT PEDAL WORKED AGAIN WITH NO SHAVER IN THE UNIT. THIS ONLY WORKED THE FIRST TIME AND USED THE PEDAL THEN WHEN THEY WENT BACK TO IT, NEITHER PEDAL WORKED TO RUN THE SHAVER, EVEN WITH NO HANDPIECE IN IT. THAT SAME HANDPIECE AND FOOTSWITCH WORKED JUST FINE ON LOANER CONTROL UNIT JUST MOMENTS AFTER THIS ONE FAILED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147643 ↗
• MalfunctionSep 5, 2024Failure to Power Up; Failure to Power Up

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT TURNED ON AND DID NOT FUNCTION / RED LIGHT WOULD GO ON OFF. MDT USED A 3RD PARTY COMPANY TO REPLACE THE MICROCHIP INSIDE THE UNIT AND IT DIDN¿T WORK. A BRAND-NEW COVIDIEN UNIT WAS NOT WORKING. ANOTHER LIKE DEVICE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147637 ↗
• MalfunctionSep 5, 2024Intermittent Energy Output; Intermittent Energy Output

  ACCORDING TO THE REPORTER, THE DEVICE MOTOR STALLED, DOES NOT WORK AT ALL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147569 ↗
• MalfunctionSep 5, 2024Device Displays Incorrect Message; Mechanical Jam; Device Displays Incorrect Message; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING SERVICING, THE DEVICE FROZE AND GAVE AN E6 ERROR WHEN BEING RAN IN OSCILLATE OFF MODE WITH A SHAVER IN THE HANDPIECE. IT WAS WORKING FINE BEFOREHAND, BUT ONCE SHAVER WAS PLUGGED INTO HANDPIECE AND RAN IN OSCILLATE OFF MODE, IT DID NOT WORK AGAIN. THEY USED AN ALIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147504 ↗
• MalfunctionSep 5, 2024Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING SERVICING, WHEN SHAVER IS INTRODUCED INTO HANDPIECE AND THE MACHINE IS RUN IN OSCILLATE OFF MODE, THE MACHINE STOPS WORKING, THE RED LIGHT COMES ON AND YOU GET THE E6 ERROR. THE MACHINE WILL NOT START WORKING AGAIN ONCE IT HAS STOPPED. OUT OF THE BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147482 ↗
• MalfunctionSep 5, 2024Device Displays Incorrect Message; Connection Problem; Intermittent Energy Output; Device Displays Incorrect Message; Connection Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE CONTROL UNIT STOPPED WORKING AND WOULD NOT RECOGNIZE THAT A HANDPIECE WAS PLUGGED IN. RED LIGHT APPEARED (ERROR 6) ON CONTROL UNIT EVEN THOUGH HANDPIECE WAS FULLY INSERTED AND LOCKED IN. HANDPIECE AND CONTROL UNIT WORKED NORMALLY FOR THE FIRST 5-10 MINUTES OF CASE, THEN SUDDENLY STOPPED WORKING. HANDPIECE WAS TESTED ON ANOTHER CONTROL UNIT(LOANER), AND WORKED APPROPRIATELY AND WAS USED TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147469 ↗
• MalfunctionSep 5, 2024Defective Device; Defective Device

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT DOES NOT CHANGE MODES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147409 ↗
• MalfunctionSep 5, 2024Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WILL NOT GO INTO OSCILLATE MODE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20147379 ↗
• MalfunctionSep 5, 2024Device Displays Incorrect Message; Intermittent Energy Output; Device Displays Incorrect Message; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT STOPPED WORKING BUT WITH LOUD VIBRATION IN HANDPIECE AND RED LIGHT CAME ON WITH E6. REPLACED HANDPIECE AND STILL DID NOT WORK BUT BOTH HANDPIECES WORKED IN AN OLDER CONTROL UNITS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147342 ↗
• MalfunctionSep 5, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING SERVICING FOR A GYNECOLOGICAL PROCEDURE, THE UNIT DISPLAYED ERROR CODE E6. NOTHING HAPPENED (NO MO VEMENT) BUT RED LIGHT WENT ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147283 ↗
• MalfunctionSep 5, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD OUT OF BOX FAILURE, NOT RECOGNIZING HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147279 ↗
• MalfunctionSep 5, 2024Fail-Safe Problem; Mechanical Jam; Fail-Safe Problem; Mechanical Jam

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT STOPPED WINDOW LOCKING, CHANGING MODES OR ALLOWING THE BLADE TO MOVE. THE DID TRY A NEW HANDPIECE AND FOOT PEDAL BEFORE ISOLATING IT TO THE CONTROL UNIT. ANOTHER UNIT WAS USED AND WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147221 ↗
• MalfunctionSep 5, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING TESTING, THE UNIT HAD ERROR 6. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147213 ↗
• MalfunctionSep 5, 2024Failure to Power Up; Failure to Power Up

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT DID NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147210 ↗
• MalfunctionJul 15, 2024Break; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Break; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPIC RESECTION OF RETAINED PRODUCTS OF CONCEPTION, DIAGNOSTIC HYSTEROSCOPY HAD BEEN PERFORMED, AND ESTABLISHED THAT THERE WAS PATHOLOGY TO BE RESECTED. THE BLACK PLUG OF THE HANDPIECE WAS HANDED OFF TO BE CONNECTED TO THE CONTROL UNIT, BUT THE SOCKET ON THE CONTROL UNIT WOULD NOT ACCEPT THE HANDPIECE. IT COULD NOT BE PUSHED ALL OF THE WAY IN. THE HANDPIECE STOPPED APPROXIMATELY 5MM BEFORE BEING COMPLETELY PUSHED IN, RESULTING IN THE CONTROL UNIT STILL SHOWING E1 ERROR CODE FOR 'HANDPIECE MISSING'. MULTIPLE HANDPIECES WERE TRIED WITH THE SAME RESULT, CONFIRMING THAT THE PROBLEM WAS WITH THE CONTROL UNIT. A PHOTO WAS INCLUDED SHOWING THE BARCODE AND SERIAL NUMBER OF THE CONTROL UNIT. THERE WAS NO PATIENT INJURY, HOWEVER, THERE WAS AN EXTENSION OF THEATRE TIME. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE BECAUSE OF THE ISSUE. THE PROCEDURE TYPE WAS ALSO CHANGED TO A 'SUCTION D & C' TO REMOVE THE RETAINED PRODUCTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19746239 ↗
• InjuryApr 13, 2024Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING HYSTEROSCOPIC POLYPECTOMY, THE UNIT KEPT SWITCHING OFF WHILE HE WAS RESECTING THE PATHOLOGY. A DIFFERENT HANDPIECE WAS USED TO SEE IF THIS WAS THE ISSUE, BUT IT STILL SWITCHED OFF WITH A NEW HANDPIECE. THE CASE COULD NOT BE COMPLETED BECAUSE THE CONTROL UNIT KEPT SWITCHING OFF, THE PATIENT HAS TO ATTEND FOR A FURTHER PROCEDURE WHEN A NEW MACHINE IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19102620 ↗