RemB 6400099000Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 07613154938353), received between Jul 24, 2018 and Oct 17, 2025 — classified as 118 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (35 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 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT THE DEVICE METAL SHAVINGS FELL OUT OF THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES & THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324164 ↗
• MalfunctionMay 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE LEAKED FLUID 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 22002745 ↗
• MalfunctionJan 8, 2025Unintended Power Up; Unintended Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103163 ↗
• MalfunctionOct 16, 2024Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT THE DEVICE HAD METAL SHAVINGS 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 20463513 ↗
• MalfunctionOct 10, 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 20415967 ↗
• MalfunctionOct 10, 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 20415879 ↗
• MalfunctionSep 16, 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 20231488 ↗
• MalfunctionSep 12, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE DEVICE WOULD NOT ACTUATE FULLY INTO SAFE MODE 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 20202565 ↗
• MalfunctionJun 11, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE DEVICE SAFETY SWITCH WILL NOT STAY IN THE SAFETY POSITION 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 19509650 ↗
• MalfunctionJun 8, 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 19493431 ↗
• MalfunctionMay 20, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE TRIGGER WAS STICKING WITH RUN ON DURING 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 19353833 ↗
• MalfunctionMay 1, 2024Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT METAL SHAVINGS INJECTED INTO THE PATIENT DURING A CASE AT THE USER FACILITY. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT, CUSTOMER WAS NOT AWARE OF ADDITIONAL DETAILS.

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

  MAUDE report 19221175 ↗
• MalfunctionApr 10, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE HAD RUN ON 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 19080162 ↗
• MalfunctionApr 10, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  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 19079971 ↗
• MalfunctionMar 23, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE DEVICE SAFETY BAR WOULD NOT FULLY ACTUATE 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 18965608 ↗
• MalfunctionMar 19, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE DEVICE SAFETY BAR WOULD NOT FULLY ACTUATE 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 18932254 ↗
• MalfunctionMar 6, 2024Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT THE DEVICE WAS SHOOTING OUT METAL SHAVINGS DURING STERILE PROCESSING 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 18846350 ↗
• MalfunctionJan 11, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE TRIGGER STICKS WITH RUN ON 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 18499681 ↗
• MalfunctionJan 5, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE DEVICE SAFETY BAR WOULD NOT MOVE 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 18460105 ↗
• MalfunctionJan 5, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THE DEVICE SAFETY BAR SLIDES IN FORWARD AND REVERSE WHEN ONLY SET IN FORWARD DURING 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 18460096 ↗
• MalfunctionOct 18, 2023Unintended Power Up; Unintended Power Up

  THE DEVICE HAD UNINTENTIONAL 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 17956122 ↗
• MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS MISSING A TRIGGER 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 17944230 ↗
• MalfunctionSep 27, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE WOULD NOT STOP RUNNING 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 17823773 ↗
• MalfunctionJul 21, 2023Unintended Movement; Unintended Movement

  THE DEVICE RAN IN THE WRONG MODE 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 17369917 ↗
• MalfunctionJul 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THAT THE DEVICE HAD A SUBSTANCE COMING OUT OF THE ROTATING PART OF THE DEVICE 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 17278555 ↗