Fusion RADRecalls & reported problems across all models

We found 2 models of Fusion RAD by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Fusion RAD recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported Fusion RAD problems

Fusion RAD models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Fusion® RAD® 1884006EM

  Neurological stereotaxic Instrument
  1 recall6 reports
• Fusion® RAD® 1884012EM

  Neurological stereotaxic Instrument
  1 recall0 reports

Recent Fusion RAD adverse event reports

The 6 most recent reports across all models, 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 ↗

Other Medtronic Xomed, Inc. products

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• StraightShot6 models · 546 reports
• NIM15 models · 410 reports · 2 recalls
• ViSAO16 models · 412 reports
• XPS Straightshot2 models · 356 reports