Skimmer 1882925HRERecalls & reported problems
Medtronic Xomed, Inc. · BLADE 1882925HRE SKIMMER 18CM 2.9MM M4 · Class 1
All models of Skimmer (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000527112), received between Jul 24, 2022 and Sep 2, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
- Use of Device Problem3
- Vibration1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2024Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED THAT THE THREE BLADES WERE DAMAGED AND NON-FUNCTIONAL. THERE WAS A 5-10 MINUTE DELAY AS MULTIPLE BLADE SWITCHES WERE REQUIRED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20115958 ↗MalfunctionSep 2, 2024Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED THAT THE THREE BLADES WERE DAMAGED AND NON-FUNCTIONAL. THERE WAS A 5-10 MINUTE DELAY AS MULTIPLE BLADE SWITCHES WERE REQUIRED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20115944 ↗MalfunctionSep 2, 2024Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED THAT THE THREE BLADES WERE DAMAGED AND NON-FUNCTIONAL. THERE WAS A 5-10 MINUTE DELAY AS MULTIPLE BLADE SWITCHES WERE REQUIRED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20115937 ↗MalfunctionApr 17, 2023Vibration; Vibration
IT WAS REPORTED THAT DURING REMOVAL OF LARYNGEAL MASS PROCEDURE, HALF WAY THROUGH THE CASE, BLADE TIP STARTED WOBBLING WHEN POWER WAS ADMINISTERED. IT WAS FURTHER REPORTED HEALTH CARE PROFESSIONAL TRIED UNCLOGGING, RE SEATING, USING A DIFFERENT HAND PIECE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16755829 ↗MalfunctionJul 24, 2022Break; Break
A HEALTHCARE PROFESSIONAL (HCP) REPORTED INTRA OP, THE DEVICE WAS BROKEN. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). NO A PROCEDURE DELAY. NO INTERVENTION PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090578 ↗
Other BUR, EAR, NOSE AND THROAT devices
- Quadcut® 1884380HRMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall7 reports
- Silver Bullet® 1882905HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall3 reports
- Diego Elite MBUR6060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall2 reports
- Quadcut® 1884380HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- RAD® 1882916Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- N/A 1884032Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
- DIEGO ELITE MBUR5060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884033HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page