MULTIGEN 2 8400-815-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327173659), received between Sep 2, 2022 and Mar 10, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 21269969 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  SALES REPRESENTATIVE REPORTED THE PROBE BROKE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560251 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  SALES REPRESENTATIVE REPORTED THE PROBE BROKE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558177 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  SALES REPRESENTATIVE REPORTED THE THE PROBE BROKE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558079 ↗
• MalfunctionOct 28, 2024Fracture; Fracture

  SALES REPRESENTATIVE REPORTED THE THE PROBE BROKE 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 20551279 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  IT WAS REPORTED THE WIRE BROKE. UPON A 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 20523729 ↗
• MalfunctionOct 23, 2024Fracture; Fracture

  IT WAS REPORTED THE WIRE BROKE. UPON A 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 20517863 ↗
• MalfunctionOct 23, 2024Fracture; Fracture

  IT WAS REPORTED THE WIRE BROKE. UPON A 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 20515188 ↗
• MalfunctionOct 15, 2024Fracture; Fracture

  IT WAS REPORTED THE WIRE BROKE. UPON A 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 20452610 ↗
• MalfunctionSep 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PROBE HANDLE BROKE OFF. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY IMPACT TO THE PATIENT. THERE WAS NO MEDICAL INTERVENTION, SURGICAL DELAYS, OR ADVERSE CONSEQUENCES DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169530 ↗
• MalfunctionMay 21, 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 19359286 ↗
• MalfunctionNov 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT HE DEVICE SHEATH 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 15707303 ↗
• MalfunctionSep 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT METAL FELL OFF OF THE DEVICE DURING TESTING. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347544 ↗