VENOM MULTIGEN 2 8400-825-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327173680), received between Aug 16, 2022 and Apr 29, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Fracture

  IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE END CAP WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028859 ↗
• InjuryNov 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE ELECTRODE BROKE OFF IN THE PATIENT'S SOFT TISSUE AND AN ADDITIONAL INCISION WAS MADE TO REMOVE THE PIECE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513409 ↗
• MalfunctionSep 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009105 ↗
• MalfunctionJul 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675035 ↗
• MalfunctionJul 28, 2025Fracture; Fracture

  IT WAS REPORTED UPON FUNCTION EVALUATION THAT THE SHEATH WAS BROKEN OFF AND MISSING, EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631735 ↗
• MalfunctionJul 28, 2025Fracture; Fracture

  IT WAS REPORTED UPON FUNCTION EVALUATION THAT THE SHEATH WAS BROKEN OFF AND MISSING, EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631734 ↗
• MalfunctionMay 8, 2025Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT THE PROBE TIPS ARE BREAKING OFF. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986122 ↗
• MalfunctionMay 8, 2025Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT THE PROBE TIPS ARE BREAKING OFF. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986120 ↗
• MalfunctionApr 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855511 ↗
• MalfunctionApr 15, 2025Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT THE PROBE BROKE OFF AT THE HANDLE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838689 ↗
• MalfunctionJan 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION IT WAS DETERMINED THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057616 ↗
• MalfunctionNov 6, 2024Fracture; Fracture

  SALES REPRESENTATIVE REPORTED THAT THE WIRE BROKE OFF DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. WAITING FOR PRODUCT TO BE RETURNED FOR FUNCTIONAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625392 ↗
• MalfunctionMay 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE ELECTRODE BROKE OFF DURING THE CASE. IT SHOULD BE NOTED THE THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO MEDICAL INTERVENTION, SURGICAL DELAYS, OR ADVERSE CONSEQUENCES TO THE PATIENT AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298594 ↗
• MalfunctionMay 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PROBE BROKE OFF THE ELECTRODE, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, DURING USE IN A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THERE WAS NO PATIENT IMPACT, NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221872 ↗
• MalfunctionNov 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE ELECTRODE BROKE OFF DURING A RF PROCEDURE, POSING A RISK THAT THIS MATERIAL COULD BE LEFT BEHIND IN THE PATIENT, DURING USE IN A SURGICAL PROCEDURE. AT THIS POINT NO ADDITIONAL EVENT DETAILS WERE PROVIDED, AND ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15823806 ↗
• MalfunctionAug 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN RFA PROCEDURE THE TIP OF THE PROBE WAS FOUND TO BE MISSING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES. IMAGING OF THE PATIENT DID NOT DETECT THE TIP; THE TIP LOCATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234424 ↗