RemB 6400034000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,618 adverse event reports that list this exact device (DI 07613154938292), received between Jul 24, 2018 and Jan 15, 2026 — classified as 2 injuries, 1,616 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (1,173 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,618 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Overheating of Device

  IT WAS REPORTED THE DEVICE OVERHEATED. FURTHER INFORMATION REGARDING PATIENT INVOLVEMENT WAS NOT PROVIDED BUT THE CUSTOMER; HOWEVER, NO ADVERSE CONSEQUENCES WERE ALLEGED.

  Patient problems: Insufficient Information

  MAUDE report 24081742 ↗
• MalfunctionOct 17, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES & THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323539 ↗
• MalfunctionMay 22, 2025Fracture; Fracture

  USER FACILITY REPORTED THAT BLADE BROKE INSIDE THE HANDPIECE DURING A PROCEDURE. ALL THE BROKEN PIECES OF THE BLADE WERE FOUND. NO SURGICAL DELAY AND NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071833 ↗
• MalfunctionMay 22, 2025Fracture; Fracture

  USER FACILITY REPORTED THAT 2 SAW BLADE BROKE INSIDE THE HANDPIECE DURING A PROCEDURE. IT WAS CONFIRMED THAT NO FRAGMENTS WERE FOUND IN PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071832 ↗
• MalfunctionFeb 24, 2025Unintended Power Up; Unintended Power Up

  THE MANUFACTURER SERVICE REPRESENTATIVE REPORTED UNINTENDED ACTIVATION OF DEVICE. THERE WERE NO ADVERSE CONSEQUENCES & THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446436 ↗
• MalfunctionDec 18, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE HAD RUN ON 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 20968301 ↗
• MalfunctionDec 18, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20968300 ↗
• MalfunctionDec 18, 2024Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20968298 ↗
• MalfunctionNov 25, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS GETTING HOT DURING A CASE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771144 ↗
• MalfunctionNov 25, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING SETUP AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771093 ↗
• MalfunctionNov 14, 2024Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT THE DEVICE RAN ON ITS OWN DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685487 ↗
• MalfunctionNov 14, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE WAS SLOW BRAKING DURING A DEMO VISIT AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685460 ↗
• MalfunctionOct 31, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE GENERATED HEAT DURING A CASE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20580086 ↗
• MalfunctionOct 29, 2024Unintended Power Up; Unintended Power Up

  THE DEVICE WAS RUNNING ON ITS OWN DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557284 ↗
• MalfunctionOct 28, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547031 ↗
• MalfunctionOct 24, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING A CASE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526682 ↗
• MalfunctionOct 24, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING A CASE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523811 ↗
• MalfunctionOct 15, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING SET UP AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455902 ↗
• MalfunctionOct 9, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE WAS SLOW BRAKING DURING A DEMO VISIT AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413949 ↗
• MalfunctionOct 8, 2024Overheating of Device; Overheating of Device

  THE DEVICE OVERHEATED DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397020 ↗
• MalfunctionOct 3, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THE DEVICE WAS HOT DURING A CASE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360819 ↗
• MalfunctionSep 26, 2024Device Remains Activated; Device Remains Activated

  THE DEVICE HAD RUN ON DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315286 ↗
• MalfunctionSep 26, 2024Overheating of Device; Overheating of Device

  THE DEVICE OVERHEATED DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20312079 ↗
• MalfunctionSep 23, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE DEVICE MAY RUN WHILE ON SAFETY SETTING. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20284884 ↗
• MalfunctionSep 23, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE DEVICE MAY RUN WHILE ON SAFETY SETTING. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20283965 ↗