QuadcutRecalls & reported problems across all models
Medtronic Xomed, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Quadcut model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 8 models of Quadcut by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 77 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2018 and Aug 27, 2026 — classified as 77 malfunctions.
The most frequently reported specific device problem is “Break” (39 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Quadcut recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 31, 2021Open, Classified
There was an increase in complaints related to tip breaks and wobble/vibration.
Z-0156-2022 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗
Most reported Quadcut problems
Device problems
- Break39
- Vibration34
- Material Separation3
- Noise, Audible3
- Overheating of Device3
- Mechanical Jam2
- Mechanical Problem2
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- No Consequences Or Impact To Patient3
- Insufficient Information1
Quadcut models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quadcut® 1884380HRBUR, EAR, NOSE AND THROAT1 recall7 reports
- Quadcut® 1884380HREBUR, EAR, NOSE AND THROAT1 recall1 report
- Quadcut® 1883080HREBUR, EAR, NOSE AND THROAT1 recall0 reports
- Quadcut® 1883480HREBUR, EAR, NOSE AND THROAT1 recall0 reports
- Quadcut 1884380EMNeurological stereotaxic Instrument33 reports
- Quadcut® 1884380HRBUR, EAR, NOSE AND THROAT21 reports
- Quadcut 1884006EMNeurological stereotaxic Instrument9 reports
- Quadcut 1884080EMNeurological stereotaxic Instrument6 reports
Recent Quadcut adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Vibration
It was reported that during procedure device was found vibrating. The procedure was completed using another device. There was no patient impact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50467016 ↗MalfunctionAug 24, 2026Break
It was reported that blade was broken. There was no known patient impact.
Patient problems: Insufficient Information
MAUDE report 50403995 ↗MalfunctionMar 20, 2026Break; Overheating of Device
IT WAS REPORTED THAT 2 BLADES BROKE DURING THE PROCEDURE. ONE OF THEM, THE TIP BROKE OFF AND SPIRAL WRAP CAME OFF INSIDE THE PATIENT AS THE PHYSICIAN WAS USING IT AND HAD TO RETRIEVE IT USING TWEEZERS. THE OTHER ONE BROKE, THE ENTIRE SHAFT SEEMED TO GET TO WARM, AND THE SPIRAL SHAFT BEGAN TO COME OFF, BUT WAS REMOVED BEFORE IT BROKE OFF COMPLETELY AND CAN SEE WHERE IT IS ABOUT TO BREAK OFF. TIP OF FIRST BLADE WAS VERY HOT AND WAS ONLY USED A FEW MINUTES. WHILE USING THE SECOND BLADE, THE BLADE AND HANDPIECE BOTH BECAME HOT. THE BLADES WERE BEING USED IN OSCILLATION MODE AT NORMAL SPEED. THE PROCEDURE WAS COMPLETED WITH A THIRD BLADE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647154 ↗MalfunctionMar 20, 2026Break; Overheating of Device
ADDITIONAL INFORMATION RECEIVED, THE HANDPIECE STARTED TO HEAT WITH IN A MINUTE PROBABLY 30 SECONDS OR LESS, IRRIGATION WAS USED (NORMAL SALINE) AND THE FLOW RATE WAS AT 3 CC/MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646838 ↗MalfunctionSep 11, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING SET UP THE BLADE WOBBLED WHEN ACTIVATED, SEEMS INSECURE WITH THE MICRODEBRIDER HANDLE. THE HANDPIECE WAS THE COMPONENT THAT WAS VIBRATING AND CAUSED THE BLADE TO WOBBLE. THE VIBRATING DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BLADE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23023658 ↗MalfunctionAug 11, 2025Material Separation; Material Separation
IT WAS REPORTED THAT DURING PROCEDURE, INSTRUMENT CAME APART UNEXPECTEDLY. THE EVENT OCCURRED DURING ACTIVE USE ON A PATIENT. THE HANDPIECE CAME APART. NO FRAGMENT LEFT ON PATIENT. THE COMPONENT SEPARATED WITHOUT EXCESSIVE FORCE USE ON PATIENT OR IMPROPER HANDLING. THE PROCEDURE PAUSED TO ADDRESS THE ISSUE AND ENSURE PATIENT SAFETY. THE DEVICE WAS IMMEDIATELY REMOVED, LABELLED AND SENT TO CORE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769144 ↗MalfunctionJul 8, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PROCEDURE PERFORMED WAS BILATERAL IMAGE-GUIDED ENDOSCOPIC SINUS SURGERY (BIGESS).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22434812 ↗MalfunctionJul 4, 2025Break; Break
IT WAS REPORTED, THE SURGEON OBSERVED THAT THE BLADE WAS NO LONGER ROTATING UPON ACTIVATION WITH THE FOOT PEDAL. THE SCRUB TECHNICIAN ATTEMPTED TO REMOVE THE BLADE FROM THE HANDPIECE AND CONFIRMED THAT THE BLADE DID NOT BREAK DURING REMOVAL. IT WAS NOTED THAT THE BLADE HAD BROKEN PRIOR TO THIS ATTEMPT, THE INNER BLADE BROKE APART AND FELL OFF. THE PROCEDURE WAS COMPLETED USING A ANOTHER BLADE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401655 ↗MalfunctionJun 10, 2025Vibration; Noise, Audible; Vibration; Noise, Audible
IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY FROM THE FIRST ACTIVATION OF THE STRAIGHT SHOT THERE WAS ABNORMAL SHAKING OF THE QUAD CUT BLADE AND IT WAS MAKING AN ODD SOUND. THE BLADE WAS REJECTED AND RESET IT INTO THE HAND PIECE, HOWEVER, THE PROBLEM WAS NOT RESOLVED. A NEW QUAD CUT BLADE WAS OPENED AND PLACED INTO THE SAME STRAIGHT SHOT AND NO ISSUES WERE OBSERVED. THE CASE WAS COMPLETED WITH THE BACKUP PRODUCT. THE PROCEDURE WAS EXTENDED UP TO 10 MINUTES. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175618 ↗MalfunctionMay 20, 2025Break; Break
IT WAS REPORTED THAT DURING A FESS CASES, THE BLADE WASN'T WORKING PROPERLY AND ULTIMATELY BROKE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22050921 ↗MalfunctionMay 6, 2025Break; Break
IT WAS REPORTED THAT DURING SINUS SURGERY, THE END CAME OFF OF THE BLADE NEAR WHERE THE CORD INSERTS. THERE WERE NO BROKEN PIECES REMAINING INSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED USING A BACK UP PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21967837 ↗MalfunctionMar 30, 2025Break; Break
IT WAS REPORTED THAT INTRA OPERATIVELY WHILE PERFORMING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE QUADCUT BLADE WASN'T WORKING RIGHT THEN THE BLADE BROKE OFF. THERE WERE NO FRAGMENTS OR PIECES DETACHED FROM THE BROKEN DEVICE. THERE WAS NO DELAY IN THE SURGERY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21728603 ↗MalfunctionMar 24, 2025Break; Break
IT WAS REPORTED THAT DURING PROCEDURE, BLADE BROKEN. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE IS NO PATIENT IMPACT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21675350 ↗MalfunctionMar 17, 2025Vibration; Vibration
IT WAS REPORTED THAT AFTER SET UP, THE M5 HANDPIECE HAD A CLICKING NOISE AND VIBRATING WHEN ACTIVE. THE HANDPIECE CAUSE THE BLADE TO VIBRATE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21617198 ↗MalfunctionMar 14, 2025Vibration; Vibration
IT WAS REPORTED DURING PITUITARY TUMOR RESECTION, SURGEON ACTIVATED BLADE AT 5000 RPM OSCILLATING MODE AND THERE WAS EXCESSIVE BLADE WOBBLE AND VIBRATION, A NEW BLADE WAS REPLACED AND WORKED AS EXPECTED. THE PROCEDURE WAS EXTENDED FOR 5 MINUTES. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606284 ↗
Other Medtronic Xomed, Inc. products
All Medtronic Xomed, Inc. 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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