RAD® 1884008Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20681490047481), received between Sep 8, 2017 and Jan 29, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Vibration” (4 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.

• MalfunctionJan 29, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, HE FOUND THAT THE BLADE WAS NOT ROTATING SM OOTHLY. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE TO COMPLETE THE SURGERY. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262589 ↗
• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, HE FOUND THAT THE BLADE HAD OBVIOUS SWAY. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A BLADE TO COMPLETE THE SURGERY. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21250584 ↗
• MalfunctionOct 25, 2024Vibration; Vibration

  IT WAS REPORTED THAT INTRA-OP, THE BLADE DID NOT TURN NORMALLY. THE BLADE WAS NOT CONNECTED TO ANY OTHER HANDPIECES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20530758 ↗
• MalfunctionMay 17, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE BLADE BROKE IN HALF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619829 ↗
• MalfunctionAug 3, 2018Vibration; Unintended Movement; Vibration

  A HEALTHCARE PROFESSIONAL REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE SHOOK DURING AN ADENOIDECTOMY SURGERY. THIS PROBLEM WAS NOTICED IN THE BEGINNING OF THE OPERATION. THE DOCTOR REINSTALLED THE BLADE BUT STILL COULD NOT SOLVE THE PROBLEM. FINALLY, THE DOCTOR USED ANOTHER NEW BLADE TO COMPLETE THE OPERATION. IT WAS NOTED THAT IT WAS THE INITIAL USE OF THE BLADE. THE SURGERY WAS DELAYED FOR ABOUT 5 MINUTES AND NO ERROR CODE WAS DISPLAYED ON THE CONSOLE. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7748404 ↗
• MalfunctionFeb 26, 2018Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT IN THE BEGINNING OF THE UPPP PROCEDURE, THE BLADE TIP BROKE INSIDE THE TUBE. THERE WERE NO FRAGMENTS, BUT A NEW BLADE HAD TO BE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298522 ↗
• MalfunctionSep 8, 2017Break; Break

  THE CUSTOMER REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY, THE BLADE WAS NOT SHARP ENOUGH, DID NOT CUT THE TISSUE, AND BROKE AT THE SPIRAL WRAP. THERE WAS A DELAY TO THE CASE. A REPLACEMENT BUR WAS USED TO COMPLETE THE CASE. THE BREAK DID NOT RESULT IN FRAGMENTS THAT REQUIRED RETRIEVAL FROM THE PATIENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6851413 ↗