RemB 6400062000Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 07613154945801), received between Jul 24, 2018 and Apr 28, 2025 — classified as 73 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (63 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 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DEVICE CONTIN359-2025-00958UES TO RUN IN REVERSE MODE 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 21917429 ↗
• MalfunctionJan 14, 2025Unintended Power Up; Device Remains Activated; Unintended Power Up; Device Remains Activated

  DURING TESTING AT THE USER FACILITY, THE DEVICE CONTINUES TO RUN AFTER ACTIVATION. 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 21151560 ↗
• MalfunctionOct 3, 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 20360825 ↗
• MalfunctionJun 21, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE WOULD NOT STOP WHEN IN REVERSE AT THE USER FACILITY DURING A CASE. 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 19580825 ↗
• MalfunctionFeb 21, 2024Device Remains Activated; Device Remains Activated

  I 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 18753084 ↗
• MalfunctionJan 5, 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 18460109 ↗
• MalfunctionJan 5, 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 18460108 ↗
• MalfunctionDec 11, 2023Device 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 18300093 ↗
• MalfunctionJul 7, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE HAD SEDIMENT PIECES COMING FROM THE END 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 17276823 ↗
• MalfunctionApr 11, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE HAD UNINTENTIONAL 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 16719599 ↗
• MalfunctionDec 22, 2022Device Remains Activated; Device Remains Activated

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD RUN ON WHILE IT WAS BEING SERVICED 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 16036493 ↗
• MalfunctionOct 20, 2022Device Remains Activated; Device Remains Activated

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD RUN-ON WHEN THE LEVER IS PRESSED DOWN WHILE IT WAS BEING SERVICED AT THE MANUFACTURING 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 15640920 ↗
• MalfunctionOct 17, 2022Device Remains Activated; Device Remains Activated

  THE USER FROM THE FACILITY REPORTED THAT THE DEVICE DOES NOT STAND STILL WHEN THE TRIGGER IS RELEASED (RUNNING-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 15620216 ↗
• MalfunctionSep 20, 2022Device Remains Activated; Device Remains Activated

  THE DEVICE HAD STICKY TRIGGER CAUSING IT TO RUN-ON DURING TESTING BY THE MANUFACTURER SERVICE TECHNICIAN. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15458396 ↗
• MalfunctionJul 19, 2022Device Remains Activated; Device Remains Activated

  THE DEVICE HAS INTERMITTENT RUN ON WHEN IN REVERSE DURING TESTING BY THE USER AT THE USER FACILITY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059863 ↗
• MalfunctionJul 8, 2022Device Remains Activated; Device Remains Activated

  THE DEVICE HAD STICKY TRIGGER CAUSING IT TO RUN AFTER ACTIVATION DURING TESTING BY THE MANUFACTURER SALES REP AT THE FACILITY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961210 ↗
• MalfunctionMay 7, 2022Device Remains Activated; Device Remains Activated

  THE DEVICE HAD RUN ON DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14322687 ↗
• MalfunctionApr 26, 2022Device Remains Activated; Device Remains Activated

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE RAN ON WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210571 ↗
• MalfunctionJan 4, 2022Device Remains Activated; Device Remains Activated

  THE SERVICE TECHNICIAN REPORTED THAT THE DEVICE CONTINUED TO RUN AFTER ACTIVATION WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152056 ↗
• MalfunctionNov 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  PER THE CUSTOMER THE DEVICE WAS LEAKING DURING THE CLEANING PROCESS AFTER A PROCEDURE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING CLEANING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853650 ↗
• MalfunctionOct 1, 2021Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT THE DEVICE CONTINUED TO RUN AFTER ACTIVATION WHILE IT WAS BEING USED AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562078 ↗
• MalfunctionSep 21, 2021Overheating of Device; Overheating of Device

  THE DEVICE OVERHEATED DURING A SERVICE VISIT AT THE USER FACILITY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507318 ↗
• MalfunctionSep 13, 2021Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT THE DEVICE CONTINUED TO RUN AFTER ACTIVATION WHILE IT WAS BEING TESTED AT THE USER FACILITY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12461661 ↗
• MalfunctionSep 7, 2021Device Remains Activated; Device Remains Activated

  THE SERVICE TECHNICIAN REPORTED THAT THE DEVICE CONTINUED TO RUN AFTER ACTIVATION WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432386 ↗
• MalfunctionAug 19, 2021Device Remains Activated; Device Remains Activated

  THE SERVICE TECHNICIAN REPORTED THAT THE DEVICE CONTINUED TO RUN AFTER ACTIVATION WHILE IT WAS BEING SERVICED AT THE USER FACILITY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345185 ↗