Valleylab VL2610Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884521196636), received between Feb 13, 2018 and Sep 30, 2026 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Melted” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951500 ↗
• MalfunctionAug 26, 2025Fire; Fire

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN STARTING THE DEVICE IT PRESENTS MINI FLAMES ON THE TIP LIKE SPARKS. THE ISSUE CONTINUED TO HAPPEN. THE PENCIL WAS CHANGED TO ANOTHER ONE AND IT WORKED NORMALLY. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892749 ↗
• MalfunctionJan 10, 2025Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN CHANGE OF BREAST PROSTHESIS PROCEDURE, THERE WAS APPEARANCE OF ELECTRIC ARCS AT THE BLADE/HANDLE JUNCTION AND THE PATIENT HAD A SECOND DEGREE BURN ON SUBMAMMARY FOLD. THE BURN WAS CAUSED BY BOTH JUNCTIONS OF THE PENCIL AND BLADE.

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

  MAUDE report 21124614 ↗
• MalfunctionJan 8, 2025Electrical Shorting; Electrical Shorting

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DIATHERMY PENCIL HAD A CURRENT LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107258 ↗
• MalfunctionMar 25, 2024Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, THE DEVICE HAD INSULATION ISSUE AND MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968853 ↗
• MalfunctionMar 25, 2024Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, THE DEVICE HAD INSULATION ISSUE AND MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968831 ↗
• MalfunctionJan 8, 2024Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING PROCEDURE. THE DEVICE HAD MELTED INSULATION ISSUE. AFTER 15 MINUTES USING THE DEVICE, IT BEGAN TO HEAT AND SMOKE WOULD START COMING FROM THE DEVICE AND GOT MELTED. THE ELECTRODE DID NOT BROKE OFF OR CRACKED. THE SURGERY CONTINUED WITH ANOTHER VL2610. THE SURGEON WAS NOT HARMED OR BURNED HIMSELF. AND NO DAMAGE WAS CAUSED TO THE PATIENT. THERE WAS NO PIECE THAT FELL INTO THE PATIENT. THERE WAS NO X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18470407 ↗
• MalfunctionMay 16, 2023Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SCALPEL PEN GRABBED/JAMMED BUTTONS, STAYING IN WORKING ORDER ALL THE TIME, THE DEVICE UNLOCKED AND STOPPED AFTER A WHILE OF USE. A NEW/OTHER HANDPIECE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE.

  Patient problems: Insufficient Information

  MAUDE report 16943273 ↗
• MalfunctionMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHEN REMOVING THE DEVICE PLATE, IT BURNT THE TIP OF THE SURGEON'S INDEX FINGER.

  Patient problems: Burning Sensation

  MAUDE report 16882664 ↗
• MalfunctionMay 5, 2023Smoking; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Smoking; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SURGEON ASKED TO INCREASE THE INTENSITY OF THE HIGH FREQUENCY GENERATOR. IT WAS SET ON AESTHETIC BREAST PROSTHESES. THE SETTING WAS CHANGED FROM 90/90 TO 110/110. IT WAS NOT EFFICIENT ENOUGH. A MOMENT LATER (ON THE 2ND SIDE), STILL NOT BEING EFFICIENT ENOUGH. CONNECTED THE PLUG OF THE ELECTROCARDIOGRAM TO THE OTHER SOURCE OF CONNECTION OF THE GENERATOR BUT THERE WAS NO DIFFERENCE. DECIDED TO CHANGE THE GENERATOR SOURCE, THE PLATE, THE CORD, THE ELECTROCARDIOGRAM ALL CIRCUIT. AFTER THAT SMELLED SOMETHING BURNING. IMMEDIATELY LOOK UNDER THE FIELDS TO CHECK WHERE THE SMOKE CAME OUT. THE PLATE HAD SLID DOWN THE PATIENT'S THIGH TO THE OUTSIDE. SMOKE CAME OUT. THE PLATE HAD SLID DOWN FROM THE PATIENT'S THIGH TOWARDS THE OUTSIDE AND STABILIZED ON THE OPERATING TABLE AND THE TOP OF THE PLATE HAD SHIFTED LOWER AT KNEE LEVEL. IT WAS FOLDED UP IN A TENT, IT WAS BURNT ON THE TOP RIGHT RIB. WHEN REMOVED IT BURNT THE TIP OF THE SURGEON INDEX FINGER. THE PATIENT WAS BURNT THE CURRENT HAD MADE A PASSAGE BETWEEN THE ONLY 2 SIDES OF THE PLATE IN CONTACT WITH THE SKIN. IT WAS NOTICED THAT ON THE CONTACT COLOR INDICATOR OF THE PLATE WAS ALWAYS GREEN. AT

  Patient problems: Burning Sensation

  MAUDE report 16882613 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING RIGHT TEMPORAL BONE EXCISIONAL BIOPSY, THERE WERE TWO ALTERNATIVE SITE BURNS, HAIR AND EAR. THERE WERE TWO BLISTERS ON THE RIGHT OUTER EARLOBE. NON-WOVEN ADHESIVE DRESSING WAS APPLIED OVER THE WOUND AND FUSIDINE SOAKED GAUZED (JELONET) WERE USED TO COVER THE BURNED PART OF THE EARS.

  Patient problems: Burn(s)

  MAUDE report 16690790 ↗
• MalfunctionApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD A CORD/CABLE ISSUE. INSTALLATION OF THE PATIENT AND BRUSHED WITH ALCOHOLIC BETADINE. DRYING TIME RESPECTED AND SET UP OF THE OPERATING DRAPES FOR AN INTERVENTION OF THE LUMBAR SPINE IN THE PRONE POSITION. DRAPES ARRANGED TO MINIMIZE OXIDANT BUILD-UP. NO SOURCE ENRICHED WITH OXYGEN NEARBY (PELVIS, BACK, BUTTOCKS). USE OF THE ELECTROCAUTERY FOR COAGULATION SEVERAL TIMES WITHOUT DIFFICULTY AND THEN TRIGGERING OF A FIRE ON THE BOTTOM OF THE PATIENT'S OUTFIT. FIRE EXTINGUISHED IMMEDIATELY. THE PAJAMAS HAVE PARTLY MELTED. POOR QUALITY OF THE ELECTROCAUTERY CABLE (POORLY INSULATED). IT WOULD HAVE HEATED AND WOULD BE THE CAUSE OF THE FIRE FOLLOWING CONTACT WITH THE ALCOHOLIC BETADINE. THERE WAS SECOND-DEGREE BURN (BLISTERING). DRESSING MADE WITH TULLE GRAS ON THE EXTERNAL FACE OF THE RIGHT THIGH THEN APPLICATION OF FLAMMAZINE. HEMODYNAMICALLY STABLE PATIENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 14227893 ↗
• MalfunctionMar 4, 2022Melted; Adverse Event Without Identified Device or Use Problem; Melted; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING CESARIAN SECTION, THE DEVICE WAS MELTED.

  Patient problems: Burn(s)

  MAUDE report 13672619 ↗
• InjuryJul 28, 2021Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY, THE DEVICE HAD ARCING/SPARKING. AT THE BEGINNING OF THE SURGERY, THE DEVICE DID NOT COAGULATE OR SHORT AS IT SHOULD HAVE BEEN, CAUSING MINIMAL DAMAGE AT THE BEGINNING OF THE COHORT. THERE WAS MINIMUM TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS. THE DAMAGE OCCURRED IN THE ABDOMEN, SURGICAL AREA, WHICH WAS SOLVED USING ANOTHER PENCIL GIVING CONTINUITY OF COHORT AND COAGULATION. THERE WAS NO FURTHER DAMAGE. PATIENT IS CURRENTLY WELL AND DISCHARGED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12241078 ↗
• MalfunctionJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PATIENT SUFFERED A FIRST DEGREE BURN OF A HALF CENTIMETER BY A HALF CENTER, FROM THE BROKEN CORD THAT PITCHED THE LEFT THIGH. USED HEALING CREAM AS TREATMENT. THERE WAS PATIENT'S NON-SERIOUS INJURY.

  Patient problems: Burn(s)

  MAUDE report 12200091 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A 3RD DEGREE BURN ON THE BACK SIZE OF A PALM AND WAS NOTICED AFTER THE SURGERY. IT WAS BEING TREATED WITH BURN OINTMENT. ALTHOUGH THEY USED DIFFERENT CAUTERY DEVICES, CAUTERY PLATES AND CAUTERY PENS, THEY CONTINUED TO BURN. ANOTHER DEVICE WAS USED AS THE CAUTERY PLATE DURING THIS EVENT.

  Patient problems: Full thickness (Third Degree) Burn; No Code Available

  MAUDE report 8790074 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT SUFFERED FROM 3RD DEGREE BURN ON THE FACE AROUND THE NOSE. UPON TESTING OF THE DEVICES, IT WAS SEEN THAT THE GENERATOR HAD CURRENT LEAKAGE UNDER THE FOLLOWING SETTINGS: "ATIVE", FUNCTION PURE CUT - 329MA "ATIVE", FUNCTION COAG - 196MA DISPERSIVE, FUNCTION PURE CUT - 250MA DISPERSIVE, FUNCTION COAG - 63MA. ALSO THE PENCIL WAS ARCING AND SPARKING.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 8116809 ↗
• MalfunctionNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PATIENT HAD BURNS IN VARIOUS PARTS OF THE BODY SPECIFICALLY AT THE ARMS, LEGS AND FOOT. APPARENTLY, THERE WAS LEAKAGE OF ENERGY AND THE BURNS OCCURRED DUE TO THE INADEQUATE SUBSTANCE USED FOR ASEPSIS WITH ALCOHOLIC CONTENT. IT WAS IDENTIFIED THAT THERE WAS AN AUTOMATIC ACTIVATION WHEN THE PEDAL WAS CONNECTED TO THE EQUIPMENT, AS THERE WAS POOR CONTACT IN THE PEDAL CABLE.

  Patient problems: Burn(s)

  MAUDE report 8034716 ↗
• MalfunctionMar 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ORCHIDOPEXY, THE PATIENT HAD AN UNKNOWN DEGREE OF BURN ON THE RIGHT SPERMATIC CORD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372126 ↗
• MalfunctionFeb 13, 2018Device Remains Activated; Failure to Fire; Device Remains Activated; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUT AND COAG KEYS WERE LOCKED. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7267327 ↗
• MalfunctionFeb 13, 2018Failure to Deliver Energy; Flare or Flash; Failure to Deliver Energy; Flare or Flash

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE¿S COAGULATING FUNCTION DID NOT WORK WITH POPPING WHEN TRIGGERED. AS A RESULT, DEVICE INDUCED A SMALL BURN ON THE BREASTS AND BLEEDING.

  Patient problems: Blood Loss; Burn(s)

  MAUDE report 7266895 ↗