MIDAS REX MR8 MR8-AS09 (UDI 00763000441043)Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00763000441043), received between Sep 5, 2024 and Sep 29, 2026 — classified as 133 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (38 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 133 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Insert

  It was reported that before operation, the tool could not be inserted into the attachment. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927484 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component; Naturally Worn

  It was reported that during testing, the attachment had bad bearings. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911971 ↗
• MalfunctionSep 24, 2026Naturally Worn

  It was reported that the device operated loudly and ran rough, with bad bearings reported. Onsite preventive maintenance was performed. It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877695 ↗
• MalfunctionSep 23, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873590 ↗
• MalfunctionSep 23, 2026Naturally Worn

  It was reported that the during pre-op the attachment had bearing failure. It was reported there was no patient involvement. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864419 ↗
• MalfunctionSep 15, 2026Naturally Worn

  It was reported that the attachment bearings are broken. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767587 ↗
• MalfunctionSep 15, 2026Naturally Worn

  It was reported that bearing looseness in attachment. It was reported that there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767405 ↗
• MalfunctionSep 11, 2026Loose or Intermittent Connection

  It was reported that after operation, the bearings were loose in the device. There was no patient involvement and patient impact in this event. Additional information received on evaluation that bearings were detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726673 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707398 ↗
• MalfunctionSep 9, 2026Loose or Intermittent Connection

  It was reported that bearing in attachment has come loose. There was no patient involvement. Additional information received stating loose and damaged bearing was found during evaluation made it reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50683716 ↗
• MalfunctionAug 28, 2026Difficult to Remove; Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492673 ↗
• MalfunctionAug 28, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492570 ↗
• MalfunctionAug 21, 2026Naturally Worn

  It was reported that the bearing was damaged. There was no parent involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50361081 ↗
• MalfunctionJul 2, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. AT THE TIME OF THE REPORT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689344 ↗
• MalfunctionJun 30, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WOULD NOT WORK MAY BE BEARING ISSUE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662637 ↗
• MalfunctionJun 29, 2026Difficult to Insert

  IT WAS REPORTED THAT PREOPERATIVELY TOOL WAS DIFFICULT TO BE INSERTED IN THE DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25649242 ↗
• MalfunctionJun 26, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DAMAGE BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633773 ↗
• MalfunctionJun 26, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632931 ↗
• MalfunctionJun 26, 2026Overheating of Device

  IT WAS REPORTED THAT DEVICE GETS HOT PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632619 ↗
• MalfunctionJun 25, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. .IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT LOOSE BEARING AT TUBE DISTAL WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25626437 ↗
• MalfunctionJun 25, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED OVERHEATING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622470 ↗
• MalfunctionJun 25, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620001 ↗
• MalfunctionJun 25, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT BEARINGS IS FAILED. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619903 ↗
• MalfunctionJun 25, 2026Naturally Worn

  IT WAS REPORTED THAT DEVICE HAS A DAMAGED INTERNAL BEARING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT LOOSE BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619441 ↗
• MalfunctionJun 25, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BEARING WAS FAILED DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS FALL OUT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617189 ↗