RAD® 1884012Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20681490047535), received between Jan 3, 2018 and Jan 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Vibration” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHEN THE USER INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, FOUND THAT THE BLADE HAD OBVIOUSLY SWAY. THE USER THEN TRIED TO RECONNECT THE BLADE BUT USELESS. FIANLLY, CHANGED A NEW BLADE TO PERFORM THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249391 ↗
• MalfunctionFeb 13, 2020Vibration; Dull, Blunt; Vibration; Dull, Blunt

  A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BLADE WAS CONNECTED TO THE M5 AND IT WASN¿T CUTTING WHEN HE TRIED TO USE IT. WHEN THE HCP TOOK IT OUT FROM THE PATIENT, THE BLADE WAS VIBRATING VIGOROUSLY. HE TRIED TO FIX IT ON AGAIN, BUT IT WAS STILL VIBRATING VIGOROUSLY. ANOTHER PIECE OF THE BLADE WAS OPENED, BUT THE BLADE WASN¿T CUTTING AS WELL. SO, THE HCP CHANGED THE HANDPIECE TO M4, AND IT STILL WASN¿T CUTTING AS WELL. HE DECIDED TO CHANGE TO ANOTHER CONSOLE, AFTER WHICH, THE PROCEDURE PROCEEDED SMOOTHLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706002 ↗
• MalfunctionOct 4, 2019Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT A BLADE VIBRATED ABNORMALLY AFTER BEING USED FOR 10 MINUTES DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE DOCTOR REINSTALLED THE BLADE BUT STILL COULD NOT RESOLVE THE PROBLEM. THEN, THE DOCTOR USED ANOTHER NEW BLADE TO COMPLETE THE OPERATION. THE SECOND BLADE COULD FUNCTION PROPERLY WITHOUT VIBRATION WITH THE SAME HANDPIECE. IT WAS THE INITIAL USE OF THE BLADE. NO ERROR CODE WAS DISPLAYED ON THE CONSOLE. THERE WAS A 10 MINUTE DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9156983 ↗
• MalfunctionNov 20, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT A BLADE BROKE INTO TWO PIECES WITHIN THE PATIENT'S CAVITY DURING THE PROCEDURE. THE HCP NOTED THAT THE BLADE WAS BEING USED NORMALLY WITH A HANDPIECE. THERE WAS A DELAY IN THE PROCEDURE BECAUSE THE FRAGMENT NEEDED TO BE TAKEN OUT OF THE PATIENT'S CAVITY AND CHECK IF THERE WAS ANY INJURY. 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 8089002 ↗
• MalfunctionAug 30, 2018Break; Break

  THE CUSTOMER REPORTED THAT THE TIP WAS DAMAGED SHORTLY AFTER HE BEGAN USING IT. THERE WAS NO IMPACT TO THE PATIENT, AND A NEW BLADE WAS OPENED TO CONTINUE THE FESS PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7836115 ↗
• MalfunctionJan 3, 2018Material Fragmentation; Material Fragmentation

  DURING VISUAL INSPECTION, SMALL FRAGMENTS WERE NOTED INSIDE THE OUTER TUBE MOUTH OF THE BLADE. THE SMALL FRAGMENTS WERE STUCK TO THE TIP WALL. THE FRAGMENTS APPEAR TO BE PORTIONS OF THE INNER CUTTER TIP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7162140 ↗