Valleylab FT10 VLFT10GENZDRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521640474), received between Aug 6, 2018 and Oct 19, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (8 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 16, 2026.

Recalls naming this device

1. Nov 16, 2023Open, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2025Energy Output Problem; Device Displays Incorrect Message; Energy Output Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DEVICE HAD ALARM ISSUE. IT SHOWED ERROR CODE 404 ENERGY ACTIVATION / SEALING ISSUE ON THE GENERATOR. THE DEVICE HAD INADEQUATE SEALING. THERE WAS EVIDENCE OF ENERGY DELIVERY BUT BLEEDS AFTER CUTTING AND END TONES WAS HEARD. THE JAWS WERE NOT CLEANED BECAUSE IT HAPPENED IMMEDIATELY OUT OF STERILE PACKAGING. THERE WAS ZERO GOOD SEALS. THE TISSUES THICKNESS WAS NOT VERY COMPRESSED TO LESS THAN 1.5MM OF FATTY TISSUE / OMENTUM. THE DEVICE WAS CONNECTED TO A GENERATOR WITH SOFTWARE VERSION 5.0.0.4025. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE. THE ISSUE OCCURRED DURING LYSIS OF ADHESIONS ON PERITONEUM AT THE ONSET OF THE PROCEDURE. THE PATIENT HAD A BLEEDING OF 2ML THAT DID NOT REQUIRE A BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23333799 ↗
• MalfunctionOct 19, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE GENERATOR WAS DELIVERING THE IMPROPER AMOUNT OF ENERGY WITH A SEAL-CYCLE COMPLETE TONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333656 ↗
• MalfunctionSep 26, 2024Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD A BURN ISSUE.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311894 ↗
• MalfunctionSep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PATIENT HAD URETER INJURY. FOUND TWO DAYS AFTER TOTAL LAP HYSTERECTOMY CASE COMPLETED. NO ISSUES WERE IDENTIFIED DURING PROCEDURE. PATIENT HAD NEPHROSTOMY TUBE PLACEMENT AND DELAYED URETERAL RE-IMPLANTATION. INJURY WAS THREE CM ABOVE THE URETEROVESICAL JUNCTION. UROLOGIST WAS UNABLE TO PASS A STENT AND RETROGRADE PYELOGRAM SHOWED EXTRAVASATION OF DYE AT THAT LEVEL. NO EVIDENCE OF SUTURE LIGATION. UNABLE TO ELABORATE ON ETIOLOGY OF INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17726297 ↗
• MalfunctionJun 19, 2023Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOIDECTOMY, IT WAS NOT A NOTICEABLE DEFECT, BUT IT SEEMS LIKE THERE WERE SEVERAL OCCASIONS WHEN THE SEAL OUTPUT FELT WEAK. THERE WAS NO REGRASP ALERT. END TONE WAS HEARD AND THERE WAS EVIDENCE OF ENERGY DELIVERY. THE OPERATION WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158721 ↗
• MalfunctionApr 15, 2022Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE UNIT WAS NOT SEALING.

  Patient problems: Insufficient Information

  MAUDE report 14118106 ↗
• MalfunctionOct 20, 2021Self-Activation or Keying; Smoking; Inaccurate Delivery; Connection Problem; Self-Activation or Keying; Smoking; Inaccurate Delivery; Connection Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDPIECE ACTIVATED BY ITSELF, THERE WAS NO REM ALARM AND REM RECEPTACLE STARTED SMOKING. THE PATIENT SUFFERED FROM MILD SECOND-DEGREE BURN THAT THEY BELIEVED WAS CAUSED BY THE BOVIE TIP. THE PATIENT WAS TREATED BY APPLYING BANDAGES TO THE AFFECTED AREAS.

  Patient problems: Partial thickness (Second Degree) Burn; Unspecified Tissue Injury

  MAUDE report 12666513 ↗
• MalfunctionAug 19, 2021Energy Output Problem; Failure to Align; Device Displays Incorrect Message; Connection Problem; Energy Output Problem; Failure to Align; Device Displays Incorrect Message; Connection Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD STOPPED SEALING WHEN ON A PATIENT. BIOMED SPENT 25 MINUTES TROUBLESHOOTING THE UNIT WHICH ALSO HAD A REM ERROR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343765 ↗
• MalfunctionMar 15, 2021Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SEAL FUNCTION WAS NOT WORKING CORRECTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484884 ↗
• MalfunctionJan 22, 2021Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S MONOPOLAR PORT 1 WAS ACTIVE WHEN NOTHING WAS PLUGGED INTO IT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11213729 ↗
• MalfunctionMar 5, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT WAS NOT SEALING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9795765 ↗
• MalfunctionAug 6, 2018Energy Output Problem; Self-Activation or Keying; Device Displays Incorrect Message; Connection Problem; Intermittent Energy Output; Activation Problem; Energy Output Problem; Self-Activation or Keying; Device Displays Incorrect Message; Connection Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, THE MONOPOLAR CUT MODE WAS ACTIVATED WHEN COAGULATE BUTTON WAS PRESSED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7754011 ↗