RAD® 1884016HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20885074080646), received between Dec 15, 2017 and Jul 22, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25902469 ↗
• MalfunctionDec 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING THE ESS PROCEDURE, THERE WAS AN UNUSUAL DISCOMFORT (A SENSATION THAT THE BLADE TIP WAS FLOATING). RESETTING DID NOT CHANGE THE SITUATION, SO IT WAS DETERMINED TO BE A MALFUNCTION. A SPARE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904067 ↗
• MalfunctionDec 4, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHEN TESTED THE BLADE ON THE HANDPIECE MADE A STRANGE NOISE AND DIDN'T FIT PROPERLY. THEY TRIED ON ANOTHER HANDPIECE AND THE SAME PROBLEM OCCURRED. THEY FOUND BLADE TO BE DAMAGED WITHOUT ANY FRAGMENTS. PROCEDURE WAS COMPLETED WITH BACK UP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724091 ↗
• MalfunctionJun 25, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT IN ESS PROCEDURE, THE TIP OF THE BLADE DID NOT ROTATE IN 2 OF THE SAME LOT DURING USE, THE TIP WAS DAMAGED WHICH WAS NON-SPECIFIC BROKEN, PROCEDURE WAS EXTENDED FOR A FEW MINUTES WHICH WAS NEEDED FOR REPLACEMENT OF THE DEVICE. A SPARE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329293 ↗
• MalfunctionApr 25, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHILE DOING AN ENT FUSION CASE, A 60 ROTATABLE BLADE WAS USED. IT WAS NOTED THAT THE BLADE WAS NOT ROTATING, IT WAS JUST MOVING BACK AND FORTH. A SECOND BLADE WAS OPENED, AND IT WAS ALSO NOT ROTATING, UPON FURTHER REVIEW, THE LOT NUMBERS WERE THE SAME. A 3RD BLADE WAS OPENED, WITH A DIFFERENT LOT NUMBER, AND THAT BLADE HAD NO ISSUES. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 21908586 ↗
• MalfunctionJun 1, 2022Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE BLADE DID NOT WORK CORRECTLY DURING SINUS SURGERY AND HAD THE STAFF SAVE IT. HE PROCEEDED WITH A DIFFERENT BLADE, BUT THE STAFF DID NOT KNOW THE DETAILS OF WHAT MALFUNCTIONED. ON ADDITIONAL INFORMATION, IT INDICATED THE INTERIOR OF THE BLADE BECAME DISCONNECTED. THERE WAS NO CASE DELAY NO PATIENT IMPACT. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. ADDITIONAL INFORMATION RECEIVED AND IT CLARIFIED THAT CONNECTION ISSUE WAS NOT AN ELECTRICAL CONNECTION ISSUE, IT WAS LIKE THE BLADES 2 PIECES CAME APART AND WOULD NOT OSCILLATE CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566903 ↗
• MalfunctionApr 25, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE BLADE BROKE, NO PATIENT IMPACT. OTHER BLADE OF SAME LOT # USED AND WAS WORKING FINE. ON FOLLOW-UP IT WAS REPORTED THAT NO PIECES FELL INTO PATIENT OR REPORTED. THE INCIDENT OCCURRED DURING SURGERY. AFTER SURGERY CUSTOMER DID A SCAN TO MAKE SURE NO PIECES WERE IN THE PATIENT, IT WAS ALL CLEAR. THE PROCEDURE WAS A FESS. THE PRODUCT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193081 ↗
• MalfunctionMay 13, 2021Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THE BLADE BROKE IN HALF WHILE USING ON A PATIENT. THE FRAGMENTS CAME OFF OR GOT DETACHED FROM THE DEVICE. ANOTHER BLADE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819444 ↗
• MalfunctionSep 23, 2019Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE WAS BROKEN DURING AN ESS (ENDOSCOPIC SINUS SURGERY) PROCEDURE. IT WAS NOTED THAT THERE WAS NO BROKEN PIECE(S) OF THE DEVICE THAT WAS LEFT INSIDE THE PATIENT'S BODY. IT WAS THE INITIAL USE OF THE DEVICE. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9104276 ↗
• MalfunctionDec 15, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE RAD 60 BLADE TIP DETACHED AS SOON AS THE OPERATOR BEGAN USING THE BLADE DURING AN ENDOSCOPIC SINUS SURGERY PROCEDURE. NO FRAGMENT RESULTED FROM THE BREAKAGE. THERE WAS NO PATIENT IMPACT REPORTED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7123122 ↗