MIDAS REX MR8 PM800 (UDI 00763000431013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000431013), received between Jun 9, 2025 and Jun 24, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRIOR TO THE PROCEDURE, LEAK WAS IDENTIFIED IN MOTOR. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605817 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING POST OP HOSE DETACHED FROM THE MOTOR. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470341 ↗
• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT HOSE DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439022 ↗
• MalfunctionJun 8, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE MOTOR CABLE WAS FOUND TO BE BROKEN PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430181 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE HOSE IS ALMOST COMPLETELY RIPPED OFF OF THE PLUG FOR THE MACHINE. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333476 ↗
• MalfunctionNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE THE MOTOR WAS BEING USED DURING A PROCEDURE, THE HOSE RUPTURED AND A LOUD EXPLOSION OCCURRED. THIS RESULTED IN AN AIR LEAK AND A 30-MINUTE DELAY IN THE PROCEDURE. BROKEN PIECES OF THE PRODUCT REMAINED INSIDE THE PATIENT'S BODY AND WERE SUBSEQUENTLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507840 ↗
• MalfunctionAug 21, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22867352 ↗
• MalfunctionAug 13, 2025Material Integrity Problem; Material Integrity Problem

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CABLE DAMAGED.IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792764 ↗
• MalfunctionJul 3, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398230 ↗
• MalfunctionJun 9, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOT A COMPLAINT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169263 ↗