MULTIGEN 2Recalls & reported problems across all models

We found 4 models of MULTIGEN 2 by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Jul 6, 2021 and Apr 21, 2026 — classified as 4 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Fracture” (45 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. 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

Most reported MULTIGEN 2 problems

MULTIGEN 2 models

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

• MULTIGEN 2 8400-815-015

  GENERATOR, LESION, RADIOFREQUENCY
  16 reports
• MULTIGEN 2 8400-815-010

  GENERATOR, LESION, RADIOFREQUENCY
  15 reports
• MULTIGEN 2 8400-815-005

  GENERATOR, LESION, RADIOFREQUENCY
  14 reports
• MULTIGEN 2 8400-000-000

  GENERATOR, LESION, RADIOFREQUENCY
  9 reports

Recent MULTIGEN 2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Fracture

  IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE END CAP 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 24941100 ↗
• MalfunctionDec 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE END CAP 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 23808395 ↗
• MalfunctionAug 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 22878216 ↗
• MalfunctionAug 21, 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 22865672 ↗
• 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 22668790 ↗
• 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 22668606 ↗
• MalfunctionJul 24, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE PATIENT WAS SHOCKED DURING A PROCEDURE WITH A RF GENERATOR. THE PATIENT STATED HE HAS EXPERIENCED TACHYCARDIA, CHEST PAIN, AND FATIGUE. THE PATIENT ALSO STATED HE HAS EXPERIENCED FALLS, DIFFICULTY WALKING, EXTREME PAIN, NEUROLOGICAL ISSUES, AND A THIRD-DEGREE BURN. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE SHOCK OR BURN TO THE PATIENT. ADDITIONAL INFORMATION IS BEING GATHERED.

  Patient problems: Ambulation or Postural Difficulties; Arrhythmia; Chest Pain; Fall; Fatigue; Full thickness (Third Degree) Burn; High Blood Pressure/ Hypertension; No Clinical Signs, Symptoms or Conditions; Pain; Unspecified Nervous System Problem

  MAUDE report 22586178 ↗
• MalfunctionJul 1, 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 22373293 ↗
• MalfunctionMay 8, 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 21985964 ↗
• 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 21856460 ↗
• 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 21856340 ↗
• 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 21854903 ↗
• 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 21854115 ↗
• MalfunctionMar 10, 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 21560104 ↗
• MalfunctionMar 6, 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 21540251 ↗

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