RAD 1884006Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20763000518138), received between Oct 18, 2023 and Sep 28, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Vibration” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Vibration

  It was reported that during the surgery, it was discovered that the blade could not make the cut. The procedure was completed with backup product. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910716 ↗
• MalfunctionAug 5, 2026Mechanical Problem; Vibration

  It was reported that intra-op during the procedure, the rotation was not smooth, turning intermittently and unable to rotate fully into position, with a loud noise. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139076 ↗
• MalfunctionOct 17, 2025Vibration; Vibration

  IT WAS REPORTED THAT INTRA OP, UNDER GENERAL ANESTHESIA, THE PATIENT UNDERWENT BILATERAL MAXILLARY, ETHMOID, AND FRONTAL SINUS OPENING SURGERY VIA NASAL ENDOSCOPY, ALONG WITH LEFT NASAL POLYPECTOMY. THE SURGERY STARTED AT 8:45. AT 9:00, THE SURGEON INTENDED TO USE A MEDTRONIC DISPOSABLE BLADE TO RESECT THE PATHOLOGICAL TISSUE AND NASAL POLYPS. UPON PRESSING THE FOOT PEDAL, IT WAS SUDDENLY OBSERVED THAT THE MEDTRONIC HANDLE-CONNECTED BLADE WAS SHAKING SEVERELY. THE FOOT PEDAL WAS IMMEDIATELY RELEASED AND THE BLADE WAS REMOVED. AFTER RECONNECTING THE BLADE, THE SEVERE SHAKING PERSISTED. ANOTHER BATCH OF BLADES WAS USED, AND THE SHAKING DISAPPEARED, ALLOWING THE SURGERY TO CONTINUE AS PLANNED. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322983 ↗
• MalfunctionSep 2, 2025Vibration; Vibration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ENDOSCOPIC NASAL SURGERY WHERE A DISPOSABLE BLADE WAS REQUIRED. A PERFORMANCE CHECK WAS CONDUCTED BEFORE THE SURGERY, REVEALING THAT THE BLADE'S INNER CORE WAS NOT SECURELY CONNECTED, CAUSING SEVERE VIBRATION. THE BLADE WAS IMMEDIATELY REPLACED TO CONTINUE THE SURGERY, WHICH DELAYED THE SURGICAL PROGRESS. THE BLADE WAS USED FOR THE FIRST TIME, AND NO VISIBLE DAMAGE WAS NOTICED WHEN CONNECTING IT TO THE HANDPIECE FOR USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935814 ↗
• MalfunctionMay 26, 2025Break; Break

  IT WAS REPORTED THAT AFTER THE BLADE WAS INSTALLED IN THE MEDTRONIC NASOPHARYNGEAL CUTTING HANDLE, IT COULD BE USED NORMALLY. WHEN THE OPERATION WAS PERFORMED TO OPEN THE ETHMOID SINUS, IT WAS FOUND THAT THE INNER BLADE NO LONGER ROTATED AFTER THE BLADE OPENED, AND IT WAS IMPOSSIBLE TO CUT. THE HANDLE WAS STOPPED FOR INSPECTION AND IT WAS FOUND THAT THE INNER BLADE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS 10 MINUTES SURGICAL DELAY. THERE WAS NO ANY BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO FRAGMENTS DETACHED FROM THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084990 ↗
• MalfunctionApr 29, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT BLADE WAS INTACT WHEN REMOVED FROM PACKAGE AND NO DAMAGE NOTICED ON THE PACKAGE. IT WAS A NEW BLADE. DURING INTRA-OP, WHEN USED ON A PATIENT, THE INNER BLADE BECAME STUCK AND BROKE DURING HIGH-SPEED ROTATION AND COULD NOT CONTINUE TO ROTATE, WHICH COULD NOT BE OBSERVED BY THE NAKED EYE FROM THE OUTSIDE. THE SPECIFIC BREAKING POSITION COULD NOT BE OBSERVED. THE PROBLEM NOTICED AFTER 10 MINUTES OF USAGE AT 5000 RPM IN RECIPROCATING MODE. NO FRAGMENTS DETACHED FROM BROKEN DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923713 ↗
• MalfunctionMar 5, 2025Break; Connection Problem; Break; Connection Problem

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO FRAGMENTS/PIECES DETACHED FROM THE BROKEN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523557 ↗
• MalfunctionJan 30, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USAGE, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE, FOUND THAT THE BLADE HAD OBVIOUS SHAKING. THE DOCTOR TRIED TO REINSTALL THE BLADE MANY TIMES BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE AND THE NEW BLADE COULD FUNCTION NORMALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271653 ↗
• MalfunctionJan 30, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE-OP, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, HE FOUND THE BLADE HAD OBVIOUS SHAKE. THE DOCTOR TRIED TO RECONNECT THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A BLADE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271585 ↗
• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, IT WAS FOUND THAT THE BLADE ROTATE NOT SMOOTHLY. THE DOCTOR TRIED TO RECONNECT THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE TO PERFORM THE SURGERY. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261368 ↗
• MalfunctionOct 13, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATING "SURGICAL COVER FELL OFF" WAS THE ROUND METAL COVER AT THE FRONT END OF THE M2 HANDPIECE THAT FIXED THE BLADE. IT DID NOT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436584 ↗
• MalfunctionFeb 27, 2024Vibration; Vibration

  ADDITIONAL INFORMATION RECEIVED AFTER THE CONNECTION PROBLEM WAS DISCOVERED IN THE OPERATING ROOM, THE BLADE WAS REPLACED IN TIME, AND AFTER THE BLADE WAS REPLACED HANDPIECE COULD BE USED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18786544 ↗
• MalfunctionFeb 19, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING PREOPERATIVE PREPARATION PROCESS, THE CIRCLED PART OF THE ATTACHMENT COULD NOT BE STUCK WHEN CONNECTED TO THE HANDPIECE MANY TIMES, AND THE BLADE WAS UNSTABLE WHEN THE HANDPIECE WAS RUNNING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18729505 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT WHEN THE SURGEON WAS PREPARING SURGICAL INSTRUMENTS BEFORE SURGERY, OPENED THE PACKAGE AND FOUND THAT THE TAIL END OF THE INNER BLADE WAS BROKEN AND CANNOT BE USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640721 ↗
• MalfunctionJan 23, 2024Break; Break

  AS PER THE RETURNED PRODUCT ANALYSIS, THE BLADE WAS NOT BROKEN. HENCE DOES NOT MEET OUR REPORTING CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18561200 ↗
• MalfunctionOct 18, 2023Break; Break

  HCP REPORTED THAT DURING FUNCTIONAL PARANASAL SINUS FENESTRATION UNDER NASAL ENDOSCOPE FOR THE PATIENT, THE SUDDENLY EXPERIENCED ONE-TIME 0-DEGREE PLANING BLADE BROKE OFF. IT COULD NOT BE USED ANYMORE AND THE PATIENT'S SKIN WAS NOT SCRATCHED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT PRODUCT WILL NOT BE RETURNED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955680 ↗