Valleylab FT10Recalls & reported problems across all models

We found 3 models of Valleylab FT10 by Covidien LP in the FDA's device registry (GUDID). Together they are named in 1,518 adverse event reports in the FDA's MAUDE database, received between Jun 1, 2017 and Sep 30, 2026 — classified as 6 deaths, 154 injuries, 1,358 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (580 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Valleylab FT10 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported Valleylab FT10 problems

Valleylab FT10 models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Valleylab FT10 VLFT10GEN

  Electrosurgical, cutting & coagulation & accessories
  1 recall5 deaths1,062 reports
• Valleylab FT10 VLFT10GEN

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 death444 reports
• Valleylab FT10 VLFT10GENZD

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 recall12 reports

Recent Valleylab FT10 adverse event reports

The 15 most recent reports across all models, 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 ↗

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