ENT MR8Recalls & reported problems across all models
Medtronic Powered Surgical Solutions · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 482
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 9 models of ENT MR8 by Medtronic Powered Surgical Solutions in the FDA's device registry (GUDID). Together they are named in 482 adverse event reports in the FDA's MAUDE database, received between Feb 28, 2023 and Sep 30, 2026 — classified as 3 injuries, 479 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (107 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ENT MR8 problems
Device problems
- No Apparent Adverse Event190
- Overheating of Device107
- Difficult to Insert64
- Detachment of Device or Device Component58
- Naturally Worn48
- Vibration28
- Noise, Audible19
- Loss of Power17
Patient problems
- No Clinical Signs, Symptoms or Conditions459
- Insufficient Information31
- Brain Injury1
- Dural Tear1
- Nerve Damage1
- Paresis1
- Perforation1
ENT MR8 models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENT MR8 1847ATTASDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE143 reports
- ENT MR8 1847ATTSSDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE127 reports
- ENT MR8 1847ATTAVDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE97 reports
- ENT MR8 1847ATTSVDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE89 reports
- ENT MR8 1847DRLMTRDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE22 reports
- ENT MR8 1847DRLMTR-RDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 report
- ENT MR8 1847B50SCCDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 report
- ENT MR8 1847B60SCCDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 report
- ENT MR8 1847B60SCTDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 report
Recent ENT MR8 adverse event reports
The 15 most recent reports across all models, 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 30, 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943354 ↗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 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 28, 2026Detachment of Device or Device Component
Medtronic received information regarding a repair request and no alleged product deficiencies were reported. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911826 ↗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 27, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910164 ↗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, 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 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 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 17, 2026Naturally Worn
It was reported that attachment is broken. At the time of report there was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803824 ↗MalfunctionSep 17, 2026Overheating of Device
Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. There was no patient i nvolvement or complications as a result of the event. Additional information received that the alleged issue was overheating and the event occurred post-operatively. Additional information received on evaluation stated that the distal bearing was detached madethis event reportable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797810 ↗
Other Medtronic Powered Surgical Solutions products
All Medtronic Powered Surgical Solutions devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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