RemB 6400037000Recalls & reported problems

Summary

The FDA's MAUDE database contains 270 adverse event reports that list this exact device (DI 07613154938339), received between Jul 24, 2018 and Oct 22, 2025 — classified as 270 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (148 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 270 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED 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 23358860 ↗
• MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED 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 23299649 ↗
• MalfunctionJul 11, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED 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 22481064 ↗
• MalfunctionJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BUTTON SLEEVE WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152341 ↗
• MalfunctionDec 18, 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 20968297 ↗
• MalfunctionOct 22, 2024Unintended Ejection; Unintended Ejection

  THE DEVICE HAD A BLADE EJECT 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 20509408 ↗
• MalfunctionSep 18, 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 20249170 ↗
• 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 20232519 ↗
• MalfunctionSep 11, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS HEATING UP 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 20194774 ↗
• MalfunctionJun 13, 2024Device Remains Activated; Device Remains Activated

  THE DEVICE CONTINUED TO RUN 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 19533383 ↗
• MalfunctionMay 22, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED 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 19369737 ↗
• MalfunctionMay 17, 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 19346941 ↗
• MalfunctionMay 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 19294223 ↗
• MalfunctionApr 22, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE WAS SLOW BRAKING 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 19153474 ↗
• MalfunctionApr 22, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS HOT 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 19153268 ↗
• MalfunctionMar 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS DRIPPING BLACK FLUID 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 18838869 ↗
• MalfunctionFeb 23, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS BEGINNING TO HEAT UP AFTER A CASE 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 18772998 ↗
• MalfunctionDec 19, 2023Unintended Power Up; Unintended Power Up

  THE DEVICE WAS AUTOMATICALLY RUNNING WITHOUT THE FOOTSWITCH DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

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

  MAUDE report 18358162 ↗
• MalfunctionDec 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING BROWN FLUID 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 18355133 ↗
• MalfunctionDec 6, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE MOTOR BEGAN TO GET VERY 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 18279844 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE FRONT HOUSING SEPARATED 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 18255435 ↗
• MalfunctionNov 29, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING USE BEFORE A CASE 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 18232695 ↗
• MalfunctionNov 29, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING USE BEFORE A CASE 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 18232694 ↗
• MalfunctionNov 29, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED 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 18232691 ↗
• MalfunctionNov 16, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE RUNS INDEFINITELY 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 18156907 ↗