ENT MR8 1847ATTSSRecalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00763000356965), received between Aug 14, 2024 and Sep 30, 2026 — classified as 127 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (23 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. It was reported there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942248 ↗
• MalfunctionSep 28, 2026Naturally Worn

  It was reported that prior to use, the device had broken bearings. There was no patient invovled in the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911090 ↗
• MalfunctionSep 23, 2026Insufficient Device Problem Information

  It was reported that the attachment had some issue/failure that was not specific, but the customer expressed dissatisfaction with the product. There was no patient impact. Additional information was received stating that damaged bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871461 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak; Difficult to Insert

  It was reported that prior to use, the attachment rejects the burr and spits out oil. It was reported that there was no patient or staff impact. Additional information was received stating that loose distal bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835216 ↗
• MalfunctionSep 16, 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 or staff impact. Additional information was received stating that detached distal bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784215 ↗
• MalfunctionSep 16, 2026Overheating of Device; Detachment of Device or Device Component

  It was reported that during a cochlea procedure, the device was warm. After being disconnected, bearing popped out of the device. The procedure was completed using backup devices. It was reported that there was no intervention and no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784055 ↗
• MalfunctionSep 15, 2026Vibration; Detachment of Device or Device Component

  It was reported that the hospital experience several issues with broken mr8 attachments, over several months. they say it is a ring that falls out of the device. the ring is so small it could potentially fall into the patient. this has happened multiple times as they try to put the device with attachments and burrs together or when changing the burrs. the doctors complain about the handpiece trembles and shake while using it. The procedure was completed with backup product. It was reported that no broken pieces of the reported product remain inside the patient's body and the patient was alive with no injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772524 ↗
• MalfunctionSep 15, 2026Naturally Worn

  It was reported that the attachment was uneasy and running rough during the preparation for use. At the time of report, there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769779 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  It was reported that during a cochlea procedure, the device was warm. After being disconnected, bearing popped out of the device. The procedure was completed using backup devices. It was reported that there was no intervention and no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767108 ↗
• MalfunctionSep 14, 2026Overheating of Device; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763638 ↗
• MalfunctionSep 10, 2026Vibration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50708420 ↗
• MalfunctionSep 9, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. At the time of report 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 50682408 ↗
• MalfunctionSep 2, 2026No Apparent Adverse Event

  It was reported that the customer had a dissatisfaction with the product. There was no patient impact in this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50557757 ↗
• MalfunctionAug 25, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435088 ↗
• MalfunctionAug 25, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. At the time of report there was no patient impact. Additional information was received stating that detached distal bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50429482 ↗
• MalfunctionAug 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 detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50428596 ↗
• MalfunctionAug 25, 2026Difficult to Remove; Naturally Worn

  It was reported that during servicing the burr cannot be removed from the attachment and the washer was broken. At the time of the report, there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50426804 ↗
• MalfunctionAug 18, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50293724 ↗
• MalfunctionAug 14, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50248638 ↗
• MalfunctionAug 13, 2026No Apparent Adverse Event

  It was reported that during intraoperative use, the attachment was found to be faulty and not working.  It was reported that there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232896 ↗
• MalfunctionAug 13, 2026Overheating of Device; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232203 ↗
• MalfunctionAug 8, 2026Vibration

  It was reported that attachment causes the bur to vibrate excessively. It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50186202 ↗
• MalfunctionAug 7, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170273 ↗
• MalfunctionAug 7, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50170227 ↗
• MalfunctionAug 7, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170017 ↗