Valleylab FT10 VLFT10GEN (UDI 10884521548350)Recalls & reported problems

Summary

The FDA's MAUDE database contains 444 adverse event reports that list this exact device (DI 10884521548350), received between Jun 13, 2017 and Sep 19, 2025 — classified as 1 death, 36 injuries, 407 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (237 reports).

1 other recall cover devices cleared under the same FDA submission (K151649, K191601); they may or may not involve this specific model.

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 25 most recent of 444 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE SURGERY FOR CONGENITAL LUNG MALFORMATION, THE DEVICE DID NOT ACTIVATE AS THERE WAS NO REGRASP ALERT, NO END TONE AND NO EVIDENCE OF ENERGY TRANSFER AFTER MULTIPLE ATTEMPTS AND EVEN AFTER FREEING THE APPROXIMATELY 3 MM SUBCUTANEOUS FAT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093132 ↗
• MalfunctionSep 15, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, THE BLUNT TIP DEVICE WAS USED IN COMBINATION WITH THE GENERATOR. THE SEALING QUALITY WAS POOR AT MULTIPLE SITES, WITH PERSISTENT BLEEDING AND OOZING OBSERVED AFTER SEALING AND CUTTING. MOST SEALS WERE NOT ADEQUATE, DESPITE EVIDENCE OF ENERGY DELIVERY AND END TONES BEING HEARD. THE SURGEON HAD TO SPEND CONSIDERABLE TIME RE-SEALING TISSUES, WHICH SIGNIFICANTLY EXTENDED THE SURGICAL TIME AND INCREASED THE WORKLOAD. THE TISSUE BEING SEALED WAS THE GREATER OMENTUM, WITH AN APPROXIMATE THICKNESS OF 5MM. THE PROCEDURE WAS COMPLETED USING THE SAME HANDLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23052783 ↗
• MalfunctionSep 2, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING PROCEDURE; THERE WAS INADEQUATE OR PARTIAL SEALING WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THE DEVICES WERE PLUGGED INTO AN FT10 GENERATOR WITH SOFTWARE VERSION 5.0.

  Patient problems: Insufficient Information

  MAUDE report 22937237 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT, POST-OPERATIVELY, THE PATIENT HAD BLEEDING IN THE PRIMARY TONSIL AFTER THE SURGERY. PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR ADDITIONAL SURGERY TO CONTROL THE BLEEDING WITH A SUCTION COAGULATOR. THERE WAS NO IMAGING DONE. BLOOD TRANSFUSION WAS NOT NECESSARY. ANOTHER HANDPIECE WAS USED AND IT WORKED FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22936845 ↗
• MalfunctionAug 14, 2025Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, NEAR THE UTERUS, AROUND THE LIGAMENT ON THE RIGHT SIDE, THE SEALING RUPTURED AFTER SURGERY. SEALED AND OUTPUTTED THE AREA AROUND THE BLEEDING POINT WITH DEVICE MULTIPLE TIMES, BUT THE BLEEDING DID NOT STOP. IT WAS NOTED THAT THE COMPLETION SOUND WAS HEARD. THE BLEEDING DID NOT STOP EVEN WHEN OUTPUTTING USING THE SAME METHOD AS USUAL, SO A COMPETITOR¿S DEVICE WAS USED TO STOP THE BLEEDING. THERE WAS NO SENSE OF THICK TISSUE. THERE WAS AN EXTENSION OF SURGERY TIME OF ABOUT 10 MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22803858 ↗
• MalfunctionAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 TO 4 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED A SUN BURN LIKE WOUND ON SKIN AT BODY AREAS TOUCHING THE OPERATION BED. THE PATIENT HAD REDNESS ON THE BACK AND BUTTOCKS AREA, CLASSIFIED AS A FIRST-DEGREE BURN.

  Patient problems: Erythema; Superficial (First Degree) Burn

  MAUDE report 22792055 ↗
• MalfunctionJul 31, 2025Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, THERE WAS INADEQUATE OR PARTIAL SEALING WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THE DEVICE SEALED SEVERAL TIMES AS EXPECTED AND STARTED TO SHOW "SEAL CYCLE INCOMPLETE". IT WAS CLEANED REGULARLY. THE CASE WAS COMPLETED WITH SILK TIES AS IT WAS CLOSE TO THE END OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675883 ↗
• MalfunctionJul 25, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING THORACOSCOPIC ESOPHAGECTOMY, THE DEVICE'S SEALING WAS IN A HALF-CAUTERIZED STATE DURING TISSUE AND VESSEL SEALING WHEREIN THE ENERGY OUTPUT AND SEAL COMPLETION SOUND COULD BE CONFIRMED AND NO REGRASP ALERT. THE DEVICE HAD TO BE RESEALED MULTIPLE TIMES MORE THAN USUAL. A NEW DEVICE WAS USED, BUT THE SEALING EFFECT DID NOT CHANGE MUCH. THE JAW PART WAS CLEANED EVERY TIME IT GOT DIRTY. WHEN THE GENERATOR WAS ALSO REPLACED AFTERWARD, THERE WAS AN IMPROVEMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22605908 ↗
• MalfunctionJul 22, 2025Energy Spectrum Incorrect; Device Displays Incorrect Message; Connection Problem; Adverse Event Without Identified Device or Use Problem; Energy Spectrum Incorrect; Device Displays Incorrect Message; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE CABLE HAD EXPERIENCED POWER TRANSMISSION ERROR GENERATING A SMALL FLAME.

  Patient problems: Insufficient Information

  MAUDE report 22563104 ↗
• InjuryJul 15, 2025Failure to Deliver Energy; Connection Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Failure to Deliver Energy; Connection Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING TONSILLECTOMY PROCEDURE, THE DEVICE FAILED TO PRODUCE COAGULATION THERAPY AND WAS REQUIRED TO COAGULATE FOR TONSIL REMOVAL. IT WAS REMOVED AND OPENED NEW SET, UNSUCCESSFUL, REMOVED ADAPTER AND SWITCHED TO ALTERNATIVE ADAPTER TO COMPLETE THE PROCEDURE. THE PATIENT WAS READMITTED FIVE DAYS POST-OP FOR ADDITIONAL SURGERY TO RESOLVED TONSIL HEMORRHAGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22504837 ↗
• MalfunctionJul 10, 2025Smoking; Device Displays Incorrect Message; Connection Problem; Smoking; Device Displays Incorrect Message; Connection Problem

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, WHILE REMOVING A PLATE IN AN ANKLE FRACTURE THE PATIENT WAS BURNED. THE ANKLE WAS COVERED WITH GAUZE AND WHILE THE LIMB WAS DISINFECTED WITH CITROCLOREX 2% NOT ENOUGH TIME WAS WAITED FOR THE DISINFECTANT TO EVAPORATE. THE MONOPOLAR WAS ACTIVATED AND THE GAUZE CAUGHT FIRE WHICH CAUSED A 2ND DEGREE BURN ON THE PATIENT'S FOOT/ANKLE. THE UNIT HAD A SMELL OF BURNT AND DISPLAYED ERRORS. THE PATIENT'S BURN SITE TREATED WITH A GAUZE WITH HYALURONIC ACID.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22470687 ↗
• MalfunctionJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 TO 4 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED A SUN BURN LIKE WOUND ON SKIN AT BODY AREAS TOUCHING OPERATION BED. BASED ON THE PHOTOS RECEIVED, THE PATIENT HAD REDNESS AND BLISTERING ON THE BACK AND BUTTOCKS AREA, CLASSIFIED AS A SECOND-DEGREE BURN.

  Patient problems: Blister; Burn(s); Erythema

  MAUDE report 22412534 ↗
• InjuryJul 3, 2025Energy Output Problem; Device Displays Incorrect Message; Connection Problem; Energy Output Problem; Device Displays Incorrect Message; Connection Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE DEVICE HAD AN E402 ERROR CODE RIGHT AFTER ACTIVATION. REPEATED FIRM GRASPING/ACTIVATING WOULD GET AN END-TONE AND EVIDENCE OF ENERGY DELIVERY WHEN APPLIED TO THE NORMAL THICKNESS OF SHORT GASTRIC VESSELS. THE JAWS OF THE DEVICE WERE CLEANED FREQUENTLY. PATIENT BLED AFTER CUTTING AND NEEDED BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22393597 ↗
• InjuryJul 3, 2025Energy Output Problem; Device Displays Incorrect Message; Energy Output Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC MEDIAN ARCUATE LIGAMENT RELEASE, ERROR CODE E402 WAS GENERATED IMMEDIATELY DURING ROUTINE ACTIVATION WHILE TRANSECTING THE LIGAMENT. REACTIVATION WAS NECESSARY, SOMETIMES MULTIPLE REGRASP ALARM OR ALERT OCCURRED. THERE WERE ISSUES WITH ENERGY ACTIVATION AND SEALING, INCLUDING INADEQUATE OR PARTIAL SEALING DESPITE EVIDENCE OF ENERGY DELIVERY AND END TONES BEING HEARD. BLEEDING OF 250 ML WAS OBSERVED AFTER CUTTING, EVEN THOUGH THE SEAL SHOWED EVIDENCE OF ENERGY DELIVERY. THE TISSUE INVOLVED WAS A NORMAL LIGAMENT BUNDLE, AND THE JAWS WERE CLEANED SEVERAL TIMES DURING THE PROCEDURE. PROCEDURE WAS COMPLETED USING SONICISION. BLOOD TRANSFUSION WAS NECESSARY DUE TO BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22393371 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON DAY TWO POSTOPERATIVELY LAPAROSCOPIC SLEEVE GASTRECTOMY, THE PATIENT WAS NOTED TO BE UNWELL. AN ULTRASOUND CONFIRMED THE PRESENCE OF THE HEMATOMA MEASURING APPROXIMATELY 200 MILLILITERS, LOCATED ON THE OMENTUM EDGE AROUND THE SECOND FIRING. NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT WAS TRANSFERRED FROM PRIVATE HOSPITAL TO PUBLIC HOSPITAL. THE BLEEDING HAD STOPPED, ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE HEMATOMA, RESULTING IN A TWO-DAY EXTENSION OF THE HOSPITAL STAY. THE PATIENT WAS SUBSEQUENTLY DISCHARGED AND REPORTED TO BE WELL. THE CUSTOMER NOTED THAT THERE WERE NO ISSUES WITH SEALING AT THE TIME OF THE PROCEDURE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22320147 ↗
• MalfunctionJun 9, 2025Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER DURING PROCEDURE, WHEN TRYING TO SEAL/CUT A BIG BRANCH OR THE DISTAL/PROXIMAL STAMP OF THE VEIN AND ALL THE EXCESS FAT WAS RELEASED. THE DEVICE DID NOT SEAL, EITHER COMPLETELY OR PARTIALLY. THE JAWS WERE VERY STIFF AND JAMMED REPEATEDLY. THEY GOT STUCK AND COULD NOT OPEN THEM UNTIL THE LIGATION GOT OUT OF THE PATIENT'S TISSUES. ON THE MACHINE EVERYTHING WORKED CORRECTLY, THE SOUNDS AND ALL THAT NOT EVEN AN ERROR MESSAGE. THERE WAS BLEEDING AND THE DOCTOR HAD TO DO MORE CUT DOWNS AND INCISIONS TO CONTROL THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22165145 ↗
• MalfunctionMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SUSPECTED PATIENT BURN INCIDENT ON THE ARM OCCURRED INVOLVING THE UNIT. THE ELECTRICAL SURGICAL UNIT WAS TESTED FOR CORRECTIVE PERFORMANCE TO INCLUDE IN THE INVESTIGATION. NO ISSUE WITH THE UNIT, IT TESTED AND PASSED AS PER PREVENTATIVE MAINTENANCE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 22114776 ↗
• MalfunctionMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SPINAL SURGERY, THE RETURN ELECTRODE PLATE CAUSED THE PATIENT A BURN. THE SURGERY STARTED AT 7:50 AM, TWO ELECTRO SCALPEL PLATES WERE PLACED ON THE LEFT LOWER LIMB IN THE LATERAL THIGH AREA. SKIN PROTECTION MEASURES WERE PLACED DUE TO THE RISK OF INJURY SINCE THE SURGERY WAS LONGER THAN THREE HOURS. POSITIONED PATIENT PRONE DUE TO THE TYPE OF SURGERY. AT 6:40 PM, THE PATIENT TURNED AROUND AND OBSERVED THE BURN ON THE RIGHT SIDE OF THE ABDOMEN ABOUT THREE CM LONG, WITH LOSS OF INTEGRITY OF THE SKIN AND BLISTERS. THE DAMAGE OR INJURY PRESENTED TO THE PATIENT WAS A GRADE II SKIN INJURY. THE ACTION TAKEN WAS DISCUSSED WITH CIPHO WHO INDICATED TO PLACE DUODERM EXTRATHIN AND WILL CARRY OUT FOLLOW-UP. FULL SKIN WAS OBSERVED AROUND THE PLATES. THE PATIENT WAS TRANSFERRED TO THE ICU WITHOUT OTHER COMPLICATIONS. A BURN IN THE ABDOMEN WAS DETERMINED, POSSIBLY DUE TO ENERGY OUTPUT FROM THE PL ATE. THE TWO PLATES WERE DISCARDED IN THE OPERATING ROOM.

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

  MAUDE report 21713402 ↗
• MalfunctionMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT CAUSED SLIGHT BURNING OF THE HOSPITAL BEDDING. THERE WAS NO PHYSICAL DAMAGE TO THE UNIT OR BURNING OR METALLIC SMELL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709841 ↗
• MalfunctionMar 25, 2025Application Program Problem: Parameter Calculation Error; Device Displays Incorrect Message; Application Program Problem: Parameter Calculation Error; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING USE, THE HANDPIECES WERE NON-FUNCTIONAL AS THERE WAS ERROR MESSAGE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND AN FT10 GENERATOR SOFTWARE ISSUE RELATED TO THE CUSTOMER'S OPERATING SOFTWARE VERSION IN WHICH THE AUTHENTICATION CHECK GIVES AN INCORRECT ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691289 ↗
• MalfunctionMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT BURN INCIDENT OCCURRED INVOLVING THE UNIT. A FIELD SERVICE ENGINEER TESTED THE FT10 UNIT AND FOUND NO ISSUES, NOTING THAT NON-MEDTRONIC ACCESSORIES WERE USED WITH THE UNIT.

  Patient problems: Burn(s)

  MAUDE report 21634871 ↗
• MalfunctionMar 18, 2025Application Program Problem: Parameter Calculation Error; Device Displays Incorrect Message; Application Program Problem: Parameter Calculation Error; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER DURING LYSIS OF ADHESIONS, THE DEVICE HAD ERROR CODE 420 MAXIMUM NUMBER OF USES REACHED IMMEDIATELY AFTER CONNECTION WHILE PLUGGING THE DEVICE INTO THE GENERATOR. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THIS GENERATOR. THE DEVICE WAS NOT REPROCESSED BY ANOTHER COMPANY AND NOT RE-USED ON A PATIENT. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND AN FT10 GENERATOR SOFTWARE ISSUE RELATED TO THE CUSTOMER'S OPERATING SOFTWARE VERSION IN WHICH THE AUTHENTICATION CHECK GIVES AN INCORRECT ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21629978 ↗
• MalfunctionMar 7, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGY TOTAL HYSTERECTOMY, THE PATIENT HAD BURN ON THE RIGHT SIDE OF THE NECK OF SEVERAL CENTIMETERS. THE SURGICAL FIELD WAS IN THE LOWER ABDOMEN, THE RETURN ELECTRODES WERE ATTACHED TO THE THIGH AREA, AND NOTHING WAS TOUCHING THE NECK. THE SURGERY WAS WITHIN ONE HOUR, IT WAS SAID THAT THE POSSIBILITY OF BEDSORE WAS LOW/UNLIKELY. IT WAS SAID THAT THE TREATMENT WAS DONE. NO BLISTERS HAVE BEEN IDENTIFIED AT THIS TIME. IT WAS CONFIRMED THAT REDNESS OCCURRED ON THE MORNING 4 DAYS AFTER SURGERY.

  Patient problems: Burn(s)

  MAUDE report 21546749 ↗
• MalfunctionMar 6, 2025Self-Activation or Keying; Connection Problem; Self-Activation or Keying; Connection Problem

  ACCORDING TO THE REPORTER, THE UNIT'S BIPOLAR MODE AUTOMATICALLY DID NOT STOP ACTIVATION WHEN THE INSTRUMENT WAS RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534493 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, AFTER 24 HOURS, THE PATIENT HAD BLEEDING OBSERVED DIRECTLY FROM THE DEVICE SEAL. THE SURGEON STATED THE SEALS SEEMED TO TAKE LONGER THAN USUAL TO GET THE END TONE. HE DIDN'T FEEL THE TISSUE WAS ESPECIALLY THICK AND IT WAS STILL TAKING LONGER TO SEAL AN ARTERY. THE PATIENT LOST OVER 1 LITER OF BLOOD AND WAS TAKEN BACK TO SURGERY. THE SURGEON COULD SEE A SMALL ARTERIAL BLEED ALONG THE DIAPHRAGM THAT APPEARED TO HAVE BEEN PREVIOUSLY SEALED THAT WAS OPEN AND BLEEDING. THE PATIENT WAS NOT ON ANY MEDICATIONS. THE DEVICE WAS CONNECTED TO A GENERATOR WITH SOFTWARE VERSION 5.0 AT THE TIME OF THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 21525732 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151649, K191601. One submission often covers many models, so check the product and lot details in each record.

• Z-0631-2024 · Nov 16, 2023 · Open, Classified
  Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD