Midas Rex MR8 PM810-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000063986), received between Aug 23, 2024 and Jun 6, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT HOSE DETACHED WAS FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25418497 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE, HOSE DETACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330259 ↗
• MalfunctionMay 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF NO REPORTED ISSUE. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT HOSE DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267872 ↗
• MalfunctionMay 5, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS A SCHEDULED PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT IMPACT. THERE WERE ANALYSIS FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081420 ↗
• MalfunctionNov 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PNEUMATIC MOTOR HAVE  AIR LEAK. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632462 ↗
• MalfunctionNov 5, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE MOTOR DOES NOT TURN OFF EVEN WHEN THE SAFETY IS ENGAGED, THE BURR CONTINUES TO SPIN. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473362 ↗
• MalfunctionSep 16, 2025Device Remains Activated; Material Rupture; Device Remains Activated; Material Rupture

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF HOSE CUT/RUPTURED AND CONTINUES TO RUN. NO PATIENT IMPACT REPORTED.

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

  MAUDE report 23066717 ↗
• MalfunctionJun 23, 2025Device Remains Activated; Device Remains Activated

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CONTINUES TO RUN. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308714 ↗
• MalfunctionMay 30, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NO ALLEGATION. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED HOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112666 ↗
• MalfunctionMay 4, 2025Device Remains Activated; Device Remains Activated

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CONTINUES TO RUN. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21956791 ↗
• MalfunctionApr 4, 2025Device Remains Activated; Device Remains Activated

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF RUNS UNINTENTIONALLY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775837 ↗
• MalfunctionApr 4, 2025Device Remains Activated; Device Remains Activated

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CONTINUES TO RUN.  IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774044 ↗
• MalfunctionApr 4, 2025Device Remains Activated; Device Remains Activated

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CONTINUOUS TO RUN. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773837 ↗
• MalfunctionFeb 12, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363769 ↗
• MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF AIR/FLUID LEAK. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437647 ↗
• MalfunctionAug 23, 2024Loss of Power; Detachment of Device or Device Component; Loss of Power; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF LOSS OF POWER. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED HOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20046399 ↗