ENT MR8 1847ATTAVRecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00763000356996), received between Mar 7, 2024 and Sep 30, 2026 — classified as 1 injury, 96 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (21 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 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Apparent Adverse Event

  Medtronic received information regarding a planned maintenance with no alleged product deficiency. There was no patient involvement. Additional information was received stating bearing detachment was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944402 ↗
• MalfunctionSep 29, 2026Difficult to Insert

  It was reported that the attachment is not holding a burr. There is no patient impact reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927962 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894451 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

  Medtronic received information regarding a loaner return, and no alleged product deficiencies were reported. No patient impact or complications have been reported as a result of this event. Additional information received stating that bearings were detached during evaluation. Additional information received stating that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893647 ↗
• MalfunctionSep 23, 2026Overheating of Device

  It was reported that the attachment was overheating. At the time of the report, there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865372 ↗
• MalfunctionSep 22, 2026No Apparent Adverse Event

  Medtronic received information regarding a loaner return, and no alleged product deficiencies were reported. There was no patient involvement or complications as a result of the event. Additional information was received stating that detached distal bearing was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856720 ↗
• MalfunctionSep 16, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785915 ↗
• MalfunctionSep 15, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767381 ↗
• MalfunctionSep 11, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request with no alleged product deficiency. There was no patient impact.  Additional information was received stating a detached bearing was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726067 ↗
• MalfunctionAug 31, 2026Loss of Power

  It was reported that during testing, device was not rotating properly. At the time of report, there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524490 ↗
• MalfunctionAug 27, 2026Loss of Power

  It was reported that the device was not working. There was no impact to the patient at the time of report. Additional information received as detached bearings found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50470812 ↗
• MalfunctionAug 25, 2026Naturally Worn

  It was reported that the attachment was broken. There was no patient impact in this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50424981 ↗
• MalfunctionAug 18, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50293189 ↗
• MalfunctionAug 17, 2026Loss of Power; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268756 ↗
• MalfunctionAug 13, 2026Naturally Worn

  It was reported that the preparing for use bearings have gone on the the attachment. It was reported there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231114 ↗
• MalfunctionAug 7, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50178161 ↗
• MalfunctionAug 6, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155147 ↗
• MalfunctionAug 6, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50153013 ↗
• MalfunctionAug 6, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50151390 ↗
• MalfunctionAug 6, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50151350 ↗
• MalfunctionAug 5, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50141317 ↗
• MalfunctionAug 4, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130842 ↗
• MalfunctionAug 4, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50126127 ↗
• MalfunctionAug 3, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50113620 ↗
• MalfunctionAug 3, 2026Difficult to Insert; Overheating of Device; Detachment of Device or Device Component; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50112157 ↗