Valleylab FT10 VLFT10GEN (UDI 10884521516328)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,062 adverse event reports that list this exact device (DI 10884521516328), received between Jun 1, 2017 and Sep 30, 2026 — classified as 5 deaths, 118 injuries, 939 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (340 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 16, 2023Class IIOpen, Classified

   Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable

   Z-0631-2024 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,062 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Self-Activation or Keying; Connection Problem

  It was reported that prior to use, the monopolar diathermy activated by itself when the surgeon touched tissue with forceps. The foot pedal was not depressed at the time, but it had just been connected to the rear of the machine. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941658 ↗
• MalfunctionSep 30, 2026Self-Activation or Keying; Device Displays Incorrect Message; Intermittent Energy Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941444 ↗
• MalfunctionSep 29, 2026Fire; Connection Problem

  According to the reporter, during a procedure, the unit caught at the monopolar cable fire. The plug of the laparoscopic monopolar cable started to burn. The power plug was pulled and the cable was extinguished with water. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941284 ↗
• MalfunctionSep 29, 2026Self-Activation or Keying; Connection Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Burn(s)

  MAUDE report 50938597 ↗
• MalfunctionSep 29, 2026Self-Activation or Keying; Connection Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that during the gastrectomy, the Monopolar was used with the original setting at 15 but at some point it suddenly changed and blew up to 60. The Bipolar mode was activated automatically, and the Ligasure instrument was impossible to connect and function because the instrument was not recognized. The patient incurred a severe burn across the spine.

  Patient problems: Burn(s)

  MAUDE report 50936748 ↗
• MalfunctionSep 29, 2026Failure to Deliver Energy; Self-Activation or Keying

  It was reported that prior to use the VLFT10GEN device burned without activation. The cautery pencil was not being activated at the field, but it remained very hot. Hot enough to burn the surgical drapes. The unit was turned off and back on, used a new cautery pencil and the unit continued to activate the cautery pencil without the pencil being activated. Another cautery machine was brought in and used it with the same cautery pencil that was replaced, and the cautery pencil only activated when button on cautery pencil was pressed. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927268 ↗
• InjurySep 24, 2026Device Displays Incorrect Message

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

  MAUDE report 50892358 ↗
• MalfunctionSep 16, 2026Smoking

  It was reported during testing that unit smells like burning when in use. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787633 ↗
• MalfunctionSep 11, 2026Self-Activation or Keying; High Readings; Connection Problem

  It was reported that high output was observed when testing cross-coupling. During retesting, Mono 1 to Mono 2 Coag Spray at 120 W measured 222 mA on two tests. The test setup was verified, point-of-care validation was completed, and troubleshooting steps were provided. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728552 ↗
• InjurySep 11, 2026Failure to Deliver Energy; Connection Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that during the procedure, a small bowel perforation occurred in the patient following the use of the bipolar coagulation mode.

  Patient problems: Bowel Perforation

  MAUDE report 50726807 ↗
• MalfunctionSep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50671674 ↗
• MalfunctionSep 8, 2026Connection Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Burn(s)

  MAUDE report 50670266 ↗
• MalfunctionAug 11, 2026Self-Activation or Keying; Device Displays Incorrect Message

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205171 ↗
• MalfunctionAug 6, 2026Fire; Connection Problem; Material Integrity Problem

  It was reported that during operation, two monopolar diathermy cables burned down twice in a row on the FT10 directly behind the plug. Sparks were flown. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159878 ↗
• MalfunctionAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Burn(s)

  MAUDE report 50158739 ↗
• MalfunctionAug 5, 2026Self-Activation or Keying

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50141368 ↗
• MalfunctionAug 4, 2026Connection Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129060 ↗
• MalfunctionAug 3, 2026Break; Self-Activation or Keying

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122488 ↗
• MalfunctionJul 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Burn(s)

  MAUDE report 50105651 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ONE WEEK POST-TONSILLECTOMY, THE PATIENT RETURNED TO THE OUTPATIENT CLINIC WITH POSTOPERATIVE BLEEDING AT THE LEFT LOWER POLE. THE SEALED AREA DURING SURGERY WAS OBSERVED TO SHOWN STRONGER REDNESS THAN IN PREVIOUS PROCEDURES. PATIENT WAS READMITTED AND IT REQUIRED SUTURING UNDER GENERAL ANESTHESIA. PATIENT WAS DISCHARGED AFTER 1 DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25678215 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ONE WEEK POST-TONSILLECTOMY, THE PATIENT RETURNED TO THE OUTPATIENT CLINIC WITH POSTOPERATIVE BLEEDING FROM LEFT LOWER POLAR. THE SEALED AREA IN RECENT SURGERY WAS OBSERVED TO SHOWN STRONGER REDNESS THAN IN PREVIOUS PROCEDURES. PATIENT WAS READMITTED AND WAS DISCHARGED AFTER 2 DAYS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25678165 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ONE-WEEK POST-TONSILLECTOMY, THE PATIENT RETURNED TO THE OUTPATIENT CLINIC WITH POSTOPERATIVE BLEEDING FROM THE RIGHT LOWER POLE. THE SEALED AREA DURING SURGERY WAS OBSERVED TO SHOWN STRONGER REDNESS THAN IN PREVIOUS PROCEDURES. THE PATIENT WAS READMITTED AND WAS DISCHARGED AFTER 4 DAYS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25678099 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ONE WEEK POST-TONSILLECTOMY, THE PATIENT RETURNED TO THE OUTPATIENT CLINIC WITH POSTOPERATIVE BLEEDING AT LEFT LOWER POLE. THE SEALED AREA DURING SURGERY WAS OBSERVED TO SHOWN STRONGER REDNESS THAN IN PREVIOUS PROCEDURES. PATIENT WAS READMITTED AND WAS DISCHARGED 5 DAYS AFTER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25677897 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ONE WEEK POST-TONSILLECTOMY, THE PATIENT RETURNED TO THE OUTPATIENT CLINIC WITH POSTOPERATIVE BLEEDING FROM COAGULATION IN LEFT LOWER POLE AND THE RIGHT MIDDLE POLE. PATIENT WAS READMITTED AND HAD BIPOLAR TREATMENT UNDER GENERAL ANESTHESIA. THE SEALED AREA DURING SURGERY WAS OBSERVED TO SHOWN STRONGER REDNESS THAN IN PREVIOUS PROCEDURES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25677832 ↗
• MalfunctionJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN URGENT PRIMARY CESAREAN SECTION, A BURN TO THE UPPER RIGHT ABDOMEN WAS OBSERVED AT THE END OF THE PROCEDURE THAT APPEARED TO BE AN ELECTROCAUTERY INJURY INVOLVING A BOVIE. A BOVIE PAD WAS APPLIED AND THE PHYSICIAN REQUESTED ELECTROCAUTERY SETTINGS AT 30/30. AFTER THE DRAPES WERE REMOVED, A POTENTIAL ELECTROCAUTERY WOUND WAS SEEN IN THE RIGHT UPPER QUADRANT, DESCRIBED AS A 3 CM BURN WITH DEPTH UNABLE TO BE ASSESSED, AND A HOLE WAS NOTED IN THE SURGICAL DRAPE OVER THE RIGHT UPPER QUADRANT. THE BOVIE CORD, SURROUNDING CASING, AND CARRIAGE SHOWED NO DEFECTS. A PLASTIC SURGERY CONSULTATION WAS OBTAINED, AND THE ABDOMINAL WOUND WAS REPAIRED IN THE OPERATING ROOM PRIOR TO TRANSFER TO POSTPARTUM. A WOUND CONSULTATION WAS ORDERED ON POSTPARTUM FOR ASSISTANCE WITH ASSESSMENT.

  Patient problems: Burn(s)

  MAUDE report 25457394 ↗