StraightShot 1882940Recalls & reported problems
Medtronic Xomed, Inc. · BLADE 1882940 5PK INFERIOR TURB 2.9MM · Class 1
All models of StraightShot (6)
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 20763000532851), received between Jul 28, 2022 and Jul 28, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Vibration” (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
- Vibration4
- Break1
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.
MalfunctionJul 28, 2026Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50049002 ↗MalfunctionJan 31, 2025Vibration; Vibration
IT WAS REPORTED THAT WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, FOUND THE BLADE HAD OBVIOUS SHAKE. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT STILL HAD OBVIOUS SHAKE. FINALLY, THE DOCTOR CHANGED A NEW BLADE AND THE NEW BLADE COULD FUNCTION NORMALLY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21281162 ↗MalfunctionJan 30, 2025Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, HE FOUND THAT THE BLADE DOES NOT ROTATE SMOOTHLY OR VIBRATING. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE TO COMPLETE THE SURGERY. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21271276 ↗MalfunctionJul 15, 2024Vibration; Vibration
IT WAS REPORTED THAT LOADED BLADE PRIOR TO CASE AND FOUND OUT IT WAS NOT WORKING. SWITCHED TO ANOTHER BLADE AND WORKED JUST FINE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19739124 ↗MalfunctionJul 28, 2022Break; Break
THE DISTRIBUTOR REPORTED THAT DURING SEPTOPLASTY PROCEDURE, WHEN THE DOCTOR USED THE BLADE ABOUT 10 MINUTES, HE FOUND THERE WAS A METAL FILINGS AT THE TIP OF THE BLADE. TO PREVENT THE HARM TO THE PATIENT, THE DOCTOR CHANGED A NEW BLADE TO COMPLETE THE SURGERY. NO PATIENT IMPACT. NO INTERVENTION PLANNED OR PERFORMED. THE SURGERY WAS DELAYED FOR 5 MINUTES. THE BACK UP DEVICE WAS USED TO COMPLETE THE SURGERY. ON FOLLOW-UP, IT WAS REPORTED THAT THE METAL FILLINGS WERE NOT NOTICED BEFORE USING THE DEVICE AND NOT SURE THAT WAS A DEGRADED PART OF THE BLADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15124723 ↗
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.
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