Fusion® RAD® 1884006EMRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000043254), received between Oct 19, 2020 and Nov 8, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 31, 2021Open, Classified

   There was an increase in complaints related to tip breaks and wobble/vibration.

   Z-0157-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT THREE SHAVERS NEEDED TO BE OPEN BECAUSE THE DISTAL TIPS BROKE DURING THE CASE. NO FRAGMENTS DETACHED FROM THE BROKEN DEVICE. THE BROKEN PARTS WERE CONTAINED BY THE HAND PIECE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638781 ↗
• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT THREE SHAVERS NEEDED TO BE OPEN BECAUSE THE DISTAL TIPS BROKE DURING THE CASE. NO FRAGMENTS DETACHED FROM THE BROKEN DEVICE. THE BROKEN PARTS WERE CONTAINED BY THE HAND PIECE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638775 ↗
• MalfunctionDec 20, 2023Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY THREE QUADCUT BLADES HAD CHATTERING (WOBBLING) ISSUES, REMOVED BLADES, REPLACED, TRIED AGAIN BUT STILL IT WAS CHATTERING, CHANGED HADPIECE BUT STILL IT WAS CHATTERING. USER CHANGED TO A NEW BLADE RAD40 BLADE IT WAS NOT CHATTERING, BUT IT BROKE AT THE DISTAL TIP WHILE BEING USED ON THE PATIENT. THE TIP SPRUNG OUT AS SOON AS THE USER PUT IT IN THE PATIENT AND INITIATED THE BLADE TO BEGIN SHAVING. USER USED BALDE FROM DIFFIRENT LOT IT WAS NOT CHATTERING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361638 ↗
• MalfunctionAug 5, 2021Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE BLADE TIP BROKE INTO MULTIPLE PIECES DURING THE FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY) PROCEDURE. THE TIP OF THE BLADE DID NOT BREAK OFF IN THE PATIENT. THERE WAS NO UNPLANNED PROCEDURES OR UNINTENDED EQUIPMENT REQUIRED TO LOCATE AND REMOVE THE FRAGMENTS. THERE WAS NO PIECES REMAIN IN THE PATIENT. THEY BELIEVE THAT THE IMPACT ON THE PLEDGET CAUSE THE TEETH OF THE BLADE TO JAM LEADING TO THE BREAK. THE BLADE WAS RUNNING AT THE SPEED OF 5000. THERE WAS A DELAY WITH THE PROCEDURE. THERE WAS A BACK-UP DEVICE USED. THEY WERE ABLE TO PULL OUT THE PIECES FROM THE PATIENT PRIOR TO CLOSING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281381 ↗
• MalfunctionOct 20, 2020Material Separation; Material Separation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT DURING OPERATION WHEN THE DOCTOR INSERTED BLADE INTO THE PATIENT AND PRESSED THE FOOT PEDAL, THE BLADE BLEW UP IN HER HAND. PART OF THE SHAVER, THE TIP, SEPARATED FROM THE REST OF THE SHAVER BLADE. THERE WERE NO FRAGMENTS DETACHED. BOX, PACKAGE, NOR PRODUCT WAS NOT TORN BEFORE OPENING AND USING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10708828 ↗
• MalfunctionOct 19, 2020Break; Vibration; Break; Vibration

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT DURING A FESS PROCEDURE THE BLADE BROKE. IT SEEMED TO BE SHAKING TOWARD THE END OF USE DURING THE CASE AND HAD NOT BEEN IN USE FOR VERY LONG. WHEN THEY WENT TO SWAP TO A DIFFERENT BLADE THEY FOUND THE TIP HAD BEEN BROKEN. NOTHING BROKE OFF IN THE PATIENT AND NO PATIENT HARM OR DELAY TO THE CLINICAL CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10701778 ↗