VENOM MULTIGEN 2 8400-825-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327173697), received between Jun 13, 2024 and Sep 11, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 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 23028688 ↗
• MalfunctionAug 4, 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 22706363 ↗
• MalfunctionJul 30, 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 22668788 ↗
• MalfunctionMay 22, 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 22069580 ↗
• MalfunctionMay 22, 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 22069578 ↗
• 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 21985959 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  IT WAS REPORTED BY THE TECHNICAL COMMENTS THAT THE CABLE IS STRETCHED AND RIPPED EXPOSING THE INTERNAL WIRES. THE SHEATH IS 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 21874341 ↗
• MalfunctionFeb 25, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21460891 ↗
• MalfunctionJan 29, 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 21267916 ↗
• 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 21057374 ↗
• MalfunctionDec 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION IT WAS DETERMINED THE ELECTRODE HUB HAS BEEN PULLED OFF AND IS MISSING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027342 ↗
• MalfunctionOct 14, 2024Fracture; Fracture

  SALES REPRESENTATIVE REPORTED DURING STERILIZATION THAT THE PROBE SNAPPED OFF AT THE PROXIMAL END. 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 20447364 ↗
• MalfunctionJun 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PROBE SHEARED AFTER SHEATH WAS REMOVED. IT SHOULD BE NOTED THAT THE CASE WAS SUCCESSFULLY COMPLETED WITH NO IMPACT TO THE PATIENT, NO MEDICAL INTERVENTION, NO DELAYS, OR ANY ADVERSE CONSEQUENCES AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528274 ↗