RAD 1884006HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20763000518329), received between Mar 31, 2023 and Sep 11, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break

  It was reported that tip of the blade snapped into half during use. There was a unexpected or prolonged care There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50731000 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT THE BLADE TIP WAS LOOSE AND CAME OFF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975463 ↗
• MalfunctionSep 2, 2025Break; Break

  PRODUCT ANALYSIS FOUND THAT, THERE WERE NO ABNORMALITIES AS THE BLADE WAS FUNCTIONING NORMALLY WITH NO FRAGMENTS INSIDE THE SHAVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932566 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT THE BLADE TIP WAS BROKEN. SURGERIES WERE ABLE TO BE COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503998 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT THE BLADE TIP WAS BROKEN. SURGERIES WERE ABLE TO BE COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503996 ↗
• MalfunctionFeb 3, 2025Vibration; Vibration

  IT WAS REPORTED THAT THERE WAS NO NOTICEABLE BREAK WHEN THE BLADE WAS INSERTED TO THE HANDPIECE, BUT WHEN THE SURGEON STARTED TO USE IT, THERE WAS AN UNUSUAL SOUND IT CREATED AND THE BLADE WASN'T DOING WHAT IT WAS SUPPOSED TO DO, LIKE DEBRIDING. THE INNER BLADE WAS BROKEN BUT THERE WERE NO BROKEN PARTS OR PIECES DETACHED FROM THE BLADE. IT WAS REPLACED WITH A NEW ONE AS IT WASN'T USABLE AT ALL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289646 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT BEFORE SURGERY, THE BLADE WAS BROKEN. THE BLADE WAS NOT BROKEN WHILE REMOVING FROM THE PACKAGE AND WHILE INSERTING AND REMOVING FROM THE HANDPIECE. NO FRAGMENTS/PIECES DETACH FROM THE BROKEN DEVICE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21088614 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED THAT PRE-OP, THE NEWLY UNPACKED 40-DEGREE BLADE BROKE INSIDE WHEN TRIED TO ROTATE THE MICRODEBRIDER HANDPIECE, AND THERE WAS AN UNUSUAL NOISE DURING USE. PROCEDURE WAS COMPLETED WITH ANOTHER BLADE. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20721397 ↗
• MalfunctionJul 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE RAD40 BLADE FELL APART. THE BLADE STARTED COMING APART AND THE USER THEN STOPPED USING THE BLADE. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687067 ↗
• MalfunctionJul 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE RAD40 BLADE FELL APART. PIECES OF THE DEVICE FELL OFF FROM THE BLADE INTO THE PATIENT AND ALL PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687053 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE INNER TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. NO PATIENT IMPACT. ADDITIONAL INFORMATION STATES THAT BUR/BLADE WAS NOT BROKEN WHEN REMOVED FROM THE PACKAGE, BUR WAS FOUND IT STOPPED SHAVING WHEN USING, SO USER REMOVED IT FROM THE PATIENT, THEN REMOVED THE TIP, AND FOUND THE INNER PART BROKEN, NO FRAGMENTS REMAIN IN THE PATIENT AND THE BROKEN PARTS CONTAINED IN THE OUTER SHAFT THAT PREVENTED THE FRAGMENTS FROM FALLING OUT AND CONTACTING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475164 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT DURING INTRA OP OF SINUS SURGERY, THE TIP OF THE BLADE WAS BROKEN AND CAME OFF. THERE WAS NO BROKEN PIECES FOUND IN THE PATIENT SINUS. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW BLADE. PATIENT STATUS IS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658401 ↗