Valleylab FX8 VLFX8GENRecalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10884521707306), received between Dec 4, 2018 and Sep 16, 2026 — classified as 1 death, 9 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (18 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, 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 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Connection Problem; Adverse Event Without Identified Device or Use Problem

  According to the reporter, during use, an extensive burning of the negative electrode plate occurred. A new generator with the same handpiece were used and it worked successfully. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787569 ↗
• MalfunctionSep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50671587 ↗
• MalfunctionMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BURN.

  Patient problems: Burn(s)

  MAUDE report 25296358 ↗
• MalfunctionMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD FIRST DEGREE BURN SKIN IN LEG REGION WITH 2CM IN SIZE.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 25296333 ↗
• MalfunctionMay 26, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT IN BETWEEN THE SURGERY, THE PATIENT HAD 1ST DEGREE BURN IN THIGH AREA WHERE THE REM PAD WAS PLACED. THE FACILITY FULLY CHECKED THE UNIT USING ESU ANALYZER AND EST EQUIPMENT AND FOUND THAT HERE WAS NO ISSUE WITH THE GENERATOR. ALL VALUES WERE WITHIN SAFE OPERATIONAL RANGES, AND THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS.

  Patient problems: Burn(s)

  MAUDE report 25278987 ↗
• MalfunctionApr 1, 2026Energy Output Problem; Self-Activation or Keying; Connection Problem

  IT WAS REPORTED THAT EVEN IF THE FEET WERE REMOVED FROM THE BIPOLAR FOOTREST, THE DEVICE CONTINUES TO GENERATE ELECTRICITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753525 ↗
• MalfunctionMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT SUSTAINED A BURN. THE USER ONLY HAD 1 GENERATOR AND BURN INCIDENT WAS OBSERVED USING THE SAME UNIT ONLY ONCE. THEY DID NOT REPLACED THE REM PAD OR PENCIL. THERE WAS TREATMENT DONE TO THE BURN SITE E.G., APPLIED PRESCRIBED OINTMENTS ON BURN SITE, A THIN LAYER OF ANTIBACTERIAL CREAM (LIKE SILVER SULFADIAZINE) TO PREVENT INFECTION.

  Patient problems: Burn(s)

  MAUDE report 24740425 ↗
• MalfunctionMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURN.

  Patient problems: Burn(s)

  MAUDE report 24680307 ↗
• MalfunctionMar 16, 2026Adverse Event Without Identified Device or Use Problem

  DUPLICATE OF PE: (B)(4). IT WAS REPORTED THAT THE PATIENT HAD BURN.

  Patient problems: Burn(s)

  MAUDE report 24605807 ↗
• MalfunctionMar 13, 2026Failure to Calibrate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE UNIT CAUSED A PATIENT BURN AND HAD A CALIBRATION ISSUE.

  Patient problems: Burn(s)

  MAUDE report 24593942 ↗
• MalfunctionMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PATIENT HAD FIRST DEGREE SKIN BURN AT THE THIGH WERE THE REM PAD WAS PLACED. NO TREATMENT WAS DONE TO THE BURN SITE.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 24555776 ↗
• InjuryMar 2, 2026Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING PROCEDURE, THE PATIENT HAD A BURN ON THE BUTTOCKS AREA. APPLIED PRESCRIBED OINTMENTS ON BURN SITE, A THIN LAYER OF ANTIBACTERIAL CREAM (LIKE SILVER SULFADIAZINE) TO PREVENT INFECTION. THE BURN WAS CAUSED BY A NON-MEDTRONIC REM PAD. A NEW REM PAD WAS USED WITH THE SAME GENERATOR AND THERE WAS NO MORE BURN INCIDENT OBSERVED. PHOTO OBSERVATION SHOWED THAT THE PATIENT HAD A THIRD DEGREE BURN.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 24479694 ↗
• MalfunctionFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE UNIT WAS NOT WORKING AND THE PATIENT EXPERIENCED A FIRST-DEGREE BURN AT THE REM PAD SITE ON THE THIGH. HOWEVER, NO TREATMENT WAS GIVEN TO THE PATIENT.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 24387272 ↗
• MalfunctionDec 19, 2025Failure to Calibrate; Connection Problem; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BURN ON THE REM (RETURN ELECTRODE MONITORING) PART AND DEVICE CALIBRATION WAS NEEDED. THE PATIENT GOT BURNT.

  Patient problems: Burn(s)

  MAUDE report 23849881 ↗
• MalfunctionDec 9, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT, PRIOR TO USE, THE GENERATOR'S MODE WAS CHANGING FROM COAGULATION TO CUT AUTOMATICALLY. INTERMITTENTLY THIS MALFUNCTION HAPPENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756847 ↗
• MalfunctionDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COAGULATION, THE PATIENT GOT BURNED.

  Patient problems: Burn(s)

  MAUDE report 23694959 ↗
• InjuryNov 5, 2025High Readings; Connection Problem; Adverse Event Without Identified Device or Use Problem; High Readings; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE UNIT¿S BIPOLAR HAD EXCESSIVE POWER OUTPUT. THIS OCCURRED WHEN THE SURGEON WAS PREPARING TO USE BIPOLAR ELECTROCAUTERY FOR HEMOSTASIS AT STANDARD MODE POWER OF 25¿ TO COAGULATE THE BLEEDING SITE. LATER, DURING THE PROCEDURE, THE NURSE FOUND THAT THE COAGULATED TISSUE HAD AN EXCESSIVELY LARGE AND DEEP AREA OF CHARRING. THE CIRCULATING NURSE EXAMINED THE MODE AND POWER SETTING, WHICH WERE THE SAME AS PREVIOUSLY USED. HOWEVER, NEW BLEEDING SPOTS APPEARED AT THE COAGULATION SITE, WHICH INCREASED BLEEDING AND CREATED AN ADDITIONAL WOUND, THEREBY PROLONGING THE PATIENT'S RECOVERY TIME AFTER SURGERY. THE UNIT WAS REPLACED. THE FOLLOWING DAY, AFTER DISINFECTION AND STERILIZATION, THE FORCEPS WERE USED WITH A HIGH-FREQUENCY ELECTROSURGICAL GENERATOR OF THE SAME BRAND AND MODEL, BUT WITH A DIFFERENT SERIAL NUMBER. THE SAME POWER SETTING AND MODE WERE MAINTAINED THROUGHOUT THE SURGERY.

  Patient problems: Full thickness (Third Degree) Burn; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Tissue Breakdown

  MAUDE report 23475865 ↗
• InjuryNov 5, 2025Failure to Calibrate; Connection Problem; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE NEAR END OF THE PROCEDURE DURING SKIN SUTURING, THE OPERATOR USED 25W POWER FOR COAGULATION. LARGE ELECTRIC SPARKS APPEARED ON THE PATIENT'S SKIN WHEN THE PENCIL WAS ACTIVATED, AND THE PENCIL LEAKED ELECTRICITY. THE REM (RETURN ELECTRODE MONITORING) INDICATOR LIGHT ON THE UNIT REMAINED GREEN AND THE UNIT DID NOT ISSUE ANY ALARMS. THE PATIENT HAD A SUPERFICIAL SECOND-DEGREE ELECTRICAL BURN IN THE LOWER UTERINE SEGMENT OF THE LOWER ABDOMEN AND THE ROUTINE TRAVERSE INCISION OF THE C-SECTION. THE PATIENT WAS UNDER ANESTHESIA AT THE TIME OF THE ELECTRIC SHOCK INJURY WITH NO OBVIOUS DISCOMFORT. THE HOSPITAL STAY WAS PROLONGED FOR ONE AND A HALF DAYS BUT THERE WERE SCARS AT THE INCISION SITE. AT PRESENT, THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND THE SPECIFIC SIZE COULD NOT BE DETERMINED. THE SPECIFIC TREATMENT MEASURES COULD NOT BE UNDERSTOOD.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23473998 ↗
• MalfunctionOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE UNIT'S BOTTOM SIDE BUSHES WERE BURNED CONFIRMED CAUSED BY FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379228 ↗
• MalfunctionOct 23, 2025Inaccurate Delivery; Failure to Calibrate; Connection Problem; Inaccurate Delivery; Failure to Calibrate; Connection Problem

  IT WAS REPORTED THAT DURING THE NEAR END OF THE PROCEDURE DURING SKIN SUTURING, THE OPERATOR USED 25W POWER FOR COAGULATION. LARGE ELECTRIC SPARKS APPEARED ON THE PATIENT'S SKIN WHEN THE PENCIL WAS ACTIVATED, AND THE PENCIL LEAKED ELECTRICITY CAUSING NUMBNESS IN THE OPERATOR'S PALM. THE REM INDICATOR LIGHT ON THE UNIT REMAINED GREEN AND THE UNIT DID NOT ISSUE ANY ALARMS.

  Patient problems: Numbness

  MAUDE report 23368363 ↗
• MalfunctionOct 23, 2025Failure to Deliver Energy; Self-Activation or Keying; Failure to Deliver Energy; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A PROCEDURE, THE UNIT CONTINUED COAGULATING AFTER DEACTIVATION. THE PATIENT HAD A 1MM FIRST DEGREE BURN IN THE CLEAVAGE THAT WAS TREATED WITH OINTMENT. IT WAS UNKNOWN IF THE BURN WAS CAUSED BY THE HANDPIECE OR REM (RETURN ELECTRODE MONITORING) PAD. THREE DEVICES WERE RETURNED WITHOUT COMPLAINT INFORMATION.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 23367333 ↗
• MalfunctionSep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT SUSTAINED BURNS.

  Patient problems: Burn(s); Partial thickness (Second Degree) Burn

  MAUDE report 22951886 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING BREAST AUGMENTATION, THE PATIENT WAS BURNED ON THE LEG WHERE THE REM (RETURN ELECTRODE MONITOR) WAS PLACED. THE REM USED WAS NON-MEDTRONIC. PHOTO OBSERVATION BY MEDICAL SAFETY WAS TAGGED AS A 3RD DEGREE BURN.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22892978 ↗
• MalfunctionAug 21, 2025Self-Activation or Keying; Connection Problem; Self-Activation or Keying; Connection Problem

  ACCORDING TO THE REPORTER PRIOR TO USE, IT WAS DISCOVERED THAT THE UNIT INTERMITTENTLY ACTIVATED BIPOLAR MODE AUTOMATICALLY WITHOUT BEING TRIGGERED. REPLACING MULTIPLE FOOT PEDALS DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865590 ↗
• MalfunctionAug 7, 2025Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, DURING THE TONSILLECTOMY, THE SURGEON WAS PERFORMING ORAL SURGERY AND WHEN WORKING ON THE TONSILS WITH THE CAUTERY MACHINE, THE NON-MEDTRONIC HANDPIECE AND ATTACHMENT BURNED THE PATIENT ON THE TONGUE ABOUT 1 INCH X ½ INCH IN SIZE.

  Patient problems: Burn(s)

  MAUDE report 22745923 ↗