RAD® 1882916 (UDI 20721902755051)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20721902755051), received between Jan 30, 2023 and Jul 22, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Vibration” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING INTRA OP USER WAS TRYING TO USE THE MICRODEBRIDER AND THE ATTACHMENT RAD60 WAS FULLY SEATED BUT RATTLING OUT WHEN THEY TRIED TO PRESS THE FOOT SWITCH. THEY GOT A NEW RAD60, AND THEY DID NOT HAVE THE SAME ISSUE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563645 ↗
• MalfunctionMay 26, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING ENDOSCOPIC SINUS SURGERY THERE WAS NO NOTICEABLE DAMAGE ON BLADE OR PACKAGE. BLADE WAS WOBBLY WHEN IT WAS IN OPERATION. (SWAYING LEFT/RIGHT). ISSUE WAS NOTICED AT THE BEGINNING OF USE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083049 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED DURING INTRA-OP FOR FESS PROCEDURE THAT THE DEVICE HAD USED BLADE 30 SECONDS HEARD GRINDING AND DAMAGED, STOPPED. PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21674742 ↗
• MalfunctionApr 29, 2024Vibration; Vibration

  IT WAS REPORTED THAT INTRA-OPERATIVELY, USER SEEDED BLADE INTO HANDPIECE, THERE WAS CONSIDERABLE VIBRATION. USER TRIED RESETTING THE BLADE AND LOCKING THE BLADE BUT THE VIBRATION WAS CONSIDERABLE. PROCEDURE WAS COMPLETED WITH THE ANOTHER BLADE. THERE WAS DELAY OF THREE MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199664 ↗
• MalfunctionDec 1, 2023Vibration; Vibration

  IT WAS REPORTED THAT DURING NORMAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE BLADE STARTED GRINDING NOISE WHEN ENGAGES. WHEN HAND PIECE WAS IN UNLOCKED POSITION, ENTIRE BLADE ROTATED 360 DEGREES. WHEN LOCKED THE DISTAL END OF BLADE VIBRATED. THE VIBRATING DEVICE WAS USED ON A PATIENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244054 ↗
• MalfunctionNov 28, 2023Vibration; Noise, Audible; Vibration; Noise, Audible

  IT WAS REPORTED THAT DURING NORMAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE BLADE STARTED GRINDING NOISE WHEN ENGAGED. BASICALLY, WHEN THE SURGEON STEPPED ON THE FOOT PEDAL, THE ENTIRE BLADE WOULD ROTATE ON THE MICRODEBRIDER HANDPIECE. FOR EXAMPLE, THE RAD 60 WAS BENT UP AT THE 12 O¿CLOCK POSITION WHEN HE STEPPED ON THE FOOT PEDAL IT ROTATED FROM 12 TO 3 O¿CLOCK POSITION UNTIL HE STEPPED OFF THE FRONT PEDAL. THAT WAS WHEN THE HANDPIECE WAS UNLOCKED. WHEN THE HANDPIECE WAS LOCKED, THE DISTAL END OF THE BLADE WOULD VIBRATE SIGNIFICANTLY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS A PROCEDURAL DELAY OF LESS THAN 1 HOUR. THERE ARE NO PATIENT IMPLICATIONS OR AFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213879 ↗
• MalfunctionJan 30, 2023Vibration; Vibration

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT DURING FESS PROCEDURE, THE BLADE SEATED APPROPRIATELY BUT WHEN THE DOCTOR HIT THE FOOT PEDAL IT WOBBLED. THEY STOPPED USING THE BLADE AND REPLACED IT WITH ANOTHER TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16262682 ↗