MULTIGEN 2 8400-000-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327173642), received between Jul 6, 2021 and Jul 24, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 7, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT HAS A DEFIBRILLATOR AND WAS SHOCKED TWICE BY THE RFA PROCEDURE BEING DONE IN THE CERVICAL SPINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY AND NO MEDICAL INTERVENTION.

  Patient problems: Electric Shock

  MAUDE report 21098172 ↗
• MalfunctionOct 23, 2024Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, A CAUTERY TIP BURNED HOLES IN DRAPES. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT A SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516130 ↗
• MalfunctionAug 9, 2023Energy Output Problem; Insufficient Device Problem Information; Energy Output Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A RF PROCEDURE THE PATIENT, WHO HAD PACEMAKER, WAS SHOCKED. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO MEDICAL INTERVENTION OR SURGICAL DELAYS.

  Patient problems: Electric Shock; Pain

  MAUDE report 17487799 ↗
• MalfunctionAug 9, 2023Energy Output Problem; Insufficient Device Problem Information; Energy Output Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A RF PROCEDURE THE PATIENT, WHO HAD PACEMAKER, WAS SHOCKED. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO MEDICAL INTERVENTION OR SURGICAL DELAYS.

  Patient problems: Electric Shock; Pain

  MAUDE report 17487797 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NOTED SEVERE PAIN AND A "SUNBURN FEELING" ON THE RIGHT LUMBAR SPINE DURING AND FOLLOWING AN L3-S1 PROCEDURE. LIDOCAINE AND MARCAINE WERE IN USE FOR LOCAL ANESTHETIC. THE CONSOLE WAS SET TO 80°C, AND NO MALFUNCTION WAS ALLEGED WITH THE EQUIPMENT. THE ABLATION PROCEDURE ITSELF WAS COMPLETED SUCCESSFULLY USING BACKUP EQUIPMENT. THE PATIENT RETURNED FOR FACET JOINT INJECTIONS CONSISTING OF LIDOCAINE, MARCAINE, AND DEXAMETHASONE TO TREAT DYSESTHESIA DUE TO WALLERIAN DEGENERATION THAT WAS ALLEGED TO HAVE OCCURRED DURING THE ORIGINAL ABLATION PROCEDURE.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 12124581 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NOTED SEVERE PAIN AND A "SUNBURN FEELING" ON THE LEFT LUMBAR SPINE FOLLOWING AN L1-L3 PROCEDURE. LIDOCAINE AND MARCAINE WERE IN USE FOR LOCAL ANESTHETIC AND PROPOFOL WAS USED FOR GENERAL ANESTHESIA. THE CONSOLE WAS SET TO 80°C, AND NO MALFUNCTION WAS ALLEGED WITH THE EQUIPMENT. THE ABLATION PROCEDURE ITSELF WAS COMPLETED BUT UNSUCCESSFUL FOR THE TREATMENT OF PAIN. THE PATIENT RETURNED FOR FACET JOINT INJECTIONS CONSISTING OF LIDOCAINE, MARCAINE, AND DEXAMETHASONE TO TREAT DYSESTHESIA DUE TO WALLERIAN DEGENERATION THAT WAS ALLEGED TO HAVE OCCURRED DURING THE ORIGINAL ABLATION PROCEDURE.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 12124555 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NOTED SEVERE PAIN AND A "SUNBURN FEELING" ON THE LEFT LUMBAR SPINE FOLLOWING AN L3-S1 PROCEDURE. LIDOCAINE AND MARCAINE WERE IN USE FOR LOCAL ANESTHETIC AND PROPOFOL WAS USED FOR GENERAL ANESTHESIA. THE CONSOLE WAS SET TO 80°C, AND NO MALFUNCTION WAS ALLEGED WITH THE EQUIPMENT. THE ABLATION PROCEDURE ITSELF WAS COMPLETED BUT UNSUCCESSFUL FOR THE TREATMENT OF PAIN. THE PATIENT RETURNED FOR FACET JOINT INJECTIONS CONSISTING OF LIDOCAINE, MARCAINE, AND DEXAMETHASONE TO TREAT DYSESTHESIA DUE TO WALLERIAN DEGENERATION THAT WAS ALLEGED TO HAVE OCCURRED DURING THE ORIGINAL ABLATION PROCEDURE.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 12124499 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NOTED SEVERE PAIN AND A "SUNBURN FEELING" ON THE LEFT CERVICAL SPINE FOLLOWING A L3-L6 PROCEDURE. LIDOCAINE AND MARCAINE WERE IN USE FOR LOCAL ANESTHETIC. THE CONSOLE WAS SET TO 60°C, AND NO MALFUNCTION WAS ALLEGED WITH THE EQUIPMENT. THE ABLATION PROCEDURE ITSELF WAS COMPLETED BUT UNSUCCESSFUL FOR THE TREATMENT OF PAIN. THE PATIENT RETURNED FOR FACET JOINT INJECTIONS CONSISTING OF LIDOCAINE, MARCAINE, AND DEXAMETHASONE TO TREAT DYSESTHESIA DUE TO WALLERIAN DEGENERATION THAT WAS ALLEGED TO HAVE OCCURRED DURING THE ORIGINAL ABLATION PROCEDURE.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 12124359 ↗