RAD® 1884012HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20885074080608), received between Sep 14, 2017 and Jul 11, 2025 — classified as 1 injury, 9 malfunctions.

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

• MalfunctionJul 11, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING PROCEDURE, PATIENT WAS ANESTHETIZED , HANDPIECE CONNECTED TO IPC CONSOLE, RAD 12 BLADE CONNECTED TO HANDPIECE, PEDAL TEST WAS OK. THE SURGICAL PROCEDURE WAS BEGAN AND IMMEDIATELY STARTED USING THE SHAVER, WHICH WAS WORKING PERFECTLY ON THE NASAL STRUCTURES. HOWEVER, AT A CERTAIN POINT, THE RAD12 BLADE BEGAN TO VIBRATE. PHYSICIAN STOPPED USING THE DEVICE, REMOVED THE BLADE AND REPLACED IT WITH TRICUT STRAIGHT BLADE, THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485207 ↗
• MalfunctionJan 6, 2025Break; Failure to Cut; Break; Failure to Cut

  EXPIRATION DATE WAS NOT NOTICED PRIOR TO THE BLADE USAGE AND THE BLADE PACKAGE STILL SEALED (STERILE BARRIER NOT COMPROMISED) PRIOR TO USE IN THIS SURGERY THE BLADE WAS CUTTING FOR APPROXIMATELY 10-15 MINUTES AND IT STOPPED WORKING WHILE USING IN A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078928 ↗
• MalfunctionMar 12, 2020Material Separation; Material Separation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT WHEN THE NEW PRODUCT WAS OPENED DURING SET-UP, THE TIP HAD BEEN BROKEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824204 ↗
• InjuryJan 2, 2020Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT IN THE MIDDLE OF A SEPTOPLASTY PROCEDURE, THE EXTERNAL TIP OF THE PRODUCT BROKE OFF AND WAS FIRST NOTICED BY THE NURSE WHEN SHE RECEIVED IT BACK FROM THE SURGEON. WHEN THE SURGEON CHECKED THE NASAL CAVITY, HE COULD NOT FIND THE TIP. AFTER AN EXTENSIVE SEARCH AND LARYNGEAL MASK AIRWAY (LMA) WAS REMOVED, X-RAY WAS DONE AND CONFIRMED THAT THE MISSING TIP WAS IN THE PATIENT¿S STOMACH. A REPLACEMENT DEVICE WAS USED TO FINISH THE PROCEDURE. THERE WAS A 30-MINUTE DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. IT WAS NOTED THAT THE BROKEN PIECE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT WAS DISCHARGED FROM THEATRE.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 9537825 ↗
• MalfunctionDec 18, 2019Material Separation; Mechanical Jam; Material Separation; Mechanical Jam

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT WHEN THEY ATTACHED THE BLADE TO THE HANDPIECE DURING THE PROCEDURE, THE BLADE STOPPED RUNNING AND BROKE INTO TWO SEGMENTS. THERE WERE NO INTERVENTION PLANNED OR PERFORMED. THERE WERE NO BROKEN PIECES REMAINED INSIDE THE PATIENTS BODY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9488329 ↗
• MalfunctionFeb 6, 2019Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE WAS SCATTERING FROM BEFORE CONNECTING AND THERE WAS AN ANOMALY OF THE PRODUCT. THE PROCEDURE WAS DACRYOCYSTORHINOSTOMY (DCR) SURGERY. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8312526 ↗
• MalfunctionJun 7, 2018Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE BLADE FELL APART WHILE BEING USED DURING AN ENDO SINUS MAXILLARY AND ETHMOID PROCEDURE. THE TIP OF THE BLADE BROKE OFF INTO THE CAVITY; HOWEVER, THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7579573 ↗
• MalfunctionMay 24, 2018Break; Break

  THE NURSE SAID THE BUR SUDDENLY DAMAGED WHEN IT WAS BEING USED. NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7539924 ↗
• MalfunctionMar 1, 2018Break; Break

  THE CUSTOMER REPORTED THAT THE BLADE BROKE WHILE THE SURGEON STARTED USING IT. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7308083 ↗
• MalfunctionSep 14, 2017Stretched; Stretched

  THE PHYSICIAN REPORTED THAT WHILE USING THE RAD 12 BLADE THE INNER CYLINDER OF THE DEVICE WAS BROKEN. IT WAS CONFIRMED THAT AFTER ST RETCHING, A FRAGMENT OF THE SPIRAL WRAP DETACHED; HOWEVER, IT DID NOT FALL INTO THE PATIENT OR REQUIRE RETRIEVAL. A BACK-UP BLADE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6866822 ↗