RAD® 1884006HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 20885074080585), received between Jan 9, 2018 and Feb 12, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT DURING FASS PROCEDURE, BLADE BROKEN. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT, EXTENDED TIME BY 2 HOURS. CONFIRMED BY THE USER THAT NO FRAGMENTS DETACHED FROM THE DEVICE. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320529 ↗
• MalfunctionDec 25, 2025Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion

  IT WAS REPORTED THAT INTRA OP, THE BLADE WAS BROKEN AND THE TIP PROTRUDES AND SHAVING CANNOT BE PERFORMED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894524 ↗
• MalfunctionDec 25, 2025Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion

  IT WAS REPORTED THAT INTRA OP, THE BLADE WAS BROKEN AND THE TIP PROTRUDES AND SHAVING CANNOT BE PERFORMED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894520 ↗
• MalfunctionDec 25, 2025Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion

  IT WAS REPORTED THAT INTRA OP, THE BLADE WAS BROKEN AND THE TIP PROTRUDES AND SHAVING CANNOT BE PERFORMED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894519 ↗
• MalfunctionDec 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT INTRA-OP DURING ENDOSCOPIC SINUS SURGERY WHEN THE FOOTSWITCH WAS PRESSED, THE OUTER TUBE OF THE BLADE WAS DETACHED. A SPARE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755736 ↗
• MalfunctionSep 17, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT DURING INTRA-OP, THE 0-DEGREE BLADE WAS USABLE BUT GOT DAMAGED DURING USE, WHILE THE 40-DEGREE BLADE COULD NOT BE USED FROM THE START. THE USER CHECKED THE BLADES BEFORE PROCEDURE. THE BLADES WAS WORKING PROPERLY AT FIRST IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070019 ↗
• MalfunctionJul 7, 2025Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION RECEIVED THAT THE FRAGMENTS DID NOT FALL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409379 ↗
• MalfunctionJun 13, 2025Use of Device Problem; Vibration; Use of Device Problem; Vibration

  IT WAS REPORTED THAT DURING INTRA-OP OF ENDOSCOPIC SINUS SURGERY, A NEW PRODUCT WAS OPENED AND IMMEDIATELY BECAME UNUSABLE AFTER STARTING USE. UPON CHECKING, THE OUTER CYLINDER WAS EXPOSED THAN NORMAL. A SPARE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22200227 ↗
• MalfunctionFeb 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRE-OP, DUE TO THE DEFORMATION OF THE BLADE TIP, CUTTING COULD NOT BE PERFORMED PROPERLY. THE TIP OF THE BLADE WAS NOT BENT. THERE WERE NO FRAGMENTS/PIECES DETACHED FROM THE BROKEN BLADE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21448192 ↗
• MalfunctionJan 15, 2025Break; Noise, Audible; Break; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED THAT BLADE IS BEING BROKEN WHILE BEING USED ON A PATIENT. THERE WERE NO FRAGMENTS DETACHED FROM BLADE. THE BLADE WAS UNWOUNDED AND IT DID NOT BROKEN INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164792 ↗
• MalfunctionJan 14, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING ENDOSCOPIC SINUS SURGERY, BLADE'S INNER CYLINDER DOES NOT TURN. IT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21155082 ↗
• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SINUS SURGERY, WHEN THE PRODUCT WAS SET AND ROTATED, THE TIP OF THE BLADE WAS BROKEN. NO F FRAGMENTS/PIECES DETACHED FROM THE BROKEN BLADES AND THE BROKEN PARTS WERE CONTAINED IN THE HANDPIECE OR IN THE OUTER SHAFT THAT PREVENTED THEM FROM FALLING OUT AND CONTACTING THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638780 ↗
• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SINUS SURGERY, WHEN THE PRODUCT WAS SET AND ROTATED, THE TIP OF THE BLADE WAS BROKEN. NO FRAGMENTS/PIECES DETACHED FROM THE BROKEN BLADES AND THE BROKEN PARTS WERE CONTAINED IN THE HANDPIECE OR IN THE OUTER SHAFT THAT PREVENTED THEM FROM FALLING OUT AND CONTACTING THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638760 ↗
• MalfunctionSep 22, 2024Break; Break

  IT WAS REPORTED DURING PROCEDURE THAT THE INNER BLADE WAS DAMAGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20275677 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED DURING PROCEDURE THAT THE INNER BLADE WAS DAMAGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456291 ↗
• MalfunctionJan 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING ENDOSCOPIC SINUS SURGERY, THE TIP OF THE OUTER CYLINDER WAS REMOVED AFTER FIFTEEN MINUTES. FRAGMENTS DETACHED FROM THE BROKEN BLADE HOWEVER DID NOT FELL INSIDE THE NASAL CAVITY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18532900 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED THAT INTRA-OP DURING ENDOSCOPIC SINUS SURGERY, THE BLADE INITIALLY WORKED, HOWEVER, IT BECAME DEFECTIVE AND PART OF THE OUTER TUBE HAD COME OFF. THE PART OF THE OUTER CYLINDER WAS ALREADY DETACHED WHEN IT WAS NOTICED AND FRAGMENTS COULD NOT BE CONFIRMED. THE PROCEDURE WAS COMPLETED USING A BACKUP PRODUCT WITHOUT ANY DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310715 ↗
• MalfunctionApr 27, 2023Break; Break

  IT WAS REPORTED THAT DURING ENDOSCOPIC SINUS SURGERY BLADE BROKE OFF. PROCEDURE COMPLETED WITH THE BACKUP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827442 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED THAT DURING FESS PROCEDURE, THE END TIP OF THE BLADE IS BROKEN WHILE DEBRIDING .THE PRODUCT WAS FOUND DAMAGED AND THERE WERE NO BROKEN PRODUCT REMAINS INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH OTHER CONVENTIONAL HAND INSTRUMENTS . THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366296 ↗
• MalfunctionMar 22, 2021Break; Break

  ON FOLLOW-UP, IT WAS REPORTED THAT BOTH BLADES WERE USED ON THE SAME CASE. IT WAS HEARD THAT THE BLADES BROKE INTO TWO PIECES. THERE ARE NO FRAGMENTS. THE DEVICES HAVE BEEN USED SEVERAL TIMES. IT WAS FELT THAT THERE WERE MORE WAYS TO TURN THE ROTATION DISK THAN OTHER FACILITIES. IT WAS THOUGHT THAT THE NUMBER OF ROTATIONS OF DEVICE WAS TO OSCILLATE AT 5000 ROTATIONS PER MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541776 ↗
• MalfunctionMar 22, 2021Break; Break

  ON FOLLOW-UP, IT WAS REPORTED THAT BOTH BLADES WERE USED ON THE SAME CASE. IT WAS HEARD THAT THE BLADES BROKE INTO TWO PIECES. THERE WERE NO FRAGMENTS. THE DEVICES HAVE BEEN USED SEVERAL TIMES. IT WAS FELT THAT THERE WERE MORE WAYS TO TURN THE ROTATION DISK THAN OTHER FACILITIES. IT WAS THOUGHT THAT THE NUMBER OF ROTATIONS OF DEVICE WAS TO OSCILLATE AT 5000 ROTATIONS PER MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541760 ↗
• MalfunctionJan 2, 2020Break; Break

  A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE WAS BROKEN DURING USE IN AN ENDOSCOPIC SINUS SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538396 ↗
• MalfunctionOct 11, 2019Material Separation; Material Separation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT A BLADE SNAPPED DURING USE AND WAS ASKING FOR A REPLACEMENT. DURING THE PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9179234 ↗
• MalfunctionJan 9, 2018Break; Break

  THE CUSTOMER REPORTED THAT THE RAD40 CURVED BLADE STOPPED WORKING DURING ENDOSCOPIC SINUS SURGERY (ESS). THE PROCEDURE WAS COMPLETED WITH A BACK-UP PRODUCT. THE BLADE HAS SOME TYPE OF DAMAGE, BUT IT IS NOT BROKEN. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175991 ↗