MIDAS REX MR8 MR8-AS07 (UDI 00763000441036)Recalls & reported problems

Summary

The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 00763000441036), received between Aug 2, 2023 and Sep 30, 2026 — classified as 3 injuries, 229 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (79 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 232 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Naturally Worn

  It was reported that the attachment bearings gone during the inter-op. It was reported there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942968 ↗
• MalfunctionSep 30, 2026Physical Resistance/Sticking

  It was reported that the attachment was not working during the pre op. It was reported 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 50942885 ↗
• MalfunctionSep 30, 2026Overheating of Device

  It was reported that during use the device was overheating. There was no patient or staff impact. Additional information received stating detached bearing was found during evaluation made it reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941923 ↗
• MalfunctionSep 29, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. It was unknown if there was any patient involvement or complications as a result of the event. Additional information was received stating that misaligned bearings were found during evaluation. Additional information regarding the patient impact was being followed up from the facility.

  Patient problems: Insufficient Information

  MAUDE report 50929779 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929448 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component

  It was reported that the ball bearing was fell out. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928472 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  It was reported that the bearing fell out/was detached pre-operatively. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917042 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913245 ↗
• MalfunctionSep 25, 2026Naturally Worn

  It was reported that during testing, the attachment had bad bearings. It was reported that there was no patient or staff impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895248 ↗
• MalfunctionSep 24, 2026Vibration; Naturally Worn

  It was reported that during servicing the device bearings were chattering and worn. There was no patient involvement. Additional inf ormation received upon evaluation stating that there were no bearings at tube distal.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877559 ↗
• MalfunctionSep 23, 2026Physical Resistance/Sticking

  It was reported that prior to use, the cutter tool was not locking. 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 50871562 ↗
• MalfunctionSep 23, 2026No Apparent Adverse Event

  It was reported that the device had no allegation of malfunction but there were analysis findings. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869624 ↗
• MalfunctionSep 23, 2026Insufficient Device Problem Information

  It was reported that during testing, the attachment was not working well. It was reported that there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866248 ↗
• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that during intra-operative the attachment bearings were gone. There was no patient involvement and no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865012 ↗
• MalfunctionSep 23, 2026Loss of Power

  It was reported that Short yellow handpiece does not work. AT the time of report, no patient was involved. Additional information received that the bearings were found to be detached during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864461 ↗
• MalfunctionSep 16, 2026Naturally Worn

  It was reported that prior to use, the attachment bearing broken. At the time of event there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785838 ↗
• MalfunctionSep 16, 2026Difficult to Insert; Vibration

  It was reported that attachment is not securely mounted and exhibits noticeable vibration after installation. At the time of report, 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 50783399 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778353 ↗
• MalfunctionSep 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50745023 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50709211 ↗
• MalfunctionSep 9, 2026Detachment of Device or Device Component; Naturally Worn

  It was reported that prior to use, the attachment had a damaged bearing. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50685903 ↗
• MalfunctionAug 27, 2026Overheating of Device

  It was reported that pre-operatively the device had a temperature increase. There was no patient or staff impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485056 ↗
• MalfunctionAug 22, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50388320 ↗
• MalfunctionJul 28, 2026Detachment of Device or Device Component

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

  MAUDE report 50051104 ↗
• MalfunctionJul 3, 2026Loss of Power

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT FROZEN. AT THE TIME OF EVENT, THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25706690 ↗