FusionRecalls & reported problems across all models

We found 3 models of Fusion by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2017 and Sep 18, 2023 — classified as 3 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Material Separation” (28 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. 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

Most reported Fusion problems

Fusion models

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

• Fusion® 1884080EM

  Neurological stereotaxic Instrument
  43 reports
• Fusion® 1884006EM

  Neurological stereotaxic Instrument
  10 reports
• Fusion® 1884012EM

  Neurological stereotaxic Instrument
  6 reports

Recent Fusion adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2023Break; Break

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, WHEN THE DOCTOR USED THE BLADE FOR ABOUT 15 MINUTES, THE TIP OF THE INNER BLADE WAS BROKEN. FRAGMENTS FORMED FROM THE DEVICE BUT WERE CONTAINED IN THE OUTER SHAFT. SO, THE DOCTOR CHANGED TO A NEW BLADE TO COMPLETE THE SURGERY. PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763315 ↗
• MalfunctionMar 15, 2022Vibration; Material Twisted/Bent; Noise, Audible; Vibration; Material Twisted/Bent; Noise, Audible

  A HEALTH CARE PROVIDER(HCP) REPORTED VIA CALL THAT SCHAEFER SOUNDED FUNNY, WASN¿T MAKING THIS SOUND IT WAS SUPPOSED TO. THE BLADE STARTED TO WOBBLE, MEDTRONIC SALES REPRESENTATIVE TOLD THE HCP TO DISCONTINUE USE AND OPEN UP A ANOTHER BLADE. SECOND PLATE WAS USED CASE WAS FINISHED WITH NO INCIDENT. HCP ALSO MENTIONED THAT HE WAS USING THE PRODUCT IN THE APPROPRIATE MANNER. HE HIT SOME HARD BONES WITH THE SHAVER AND BENT THE TINES. THERE WAS NO INTERVENTION PLANNED/PERFORMED. THERE WAS NO PROCEDURE DELAY AND PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT. ON FOLLOW UP IT WAS MENTIONED THAT DR. HILTON SAID THE BLADE WAS WOBBLING AND NOT SOUNDING QUITE RIGHT, THEN HE ADDED I DID GO THROUGH SOME HARD BONE. THE ISSUE WAS FOUND WHILE USING ON THE PATIENT. MEDTRONIC SALES REP TOLD HIM TO DISCONTINUE USE AND OPEN ANOTHER BLADE. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE: BLADE WAS TESTED FOR WOBBLE PRIOR USING ON THE PATIENT. BLADE WORKED AS EXPECTED FOR THE FIRST HALF OF THE CASE AND THEN AS HCP WAS WORKING INTO THE POSTERIOR ETHMOID SPACE OF THE PATIENT¿S LEFT SIDE. HCP WAS WORKING ON A BONY PARTITION AND THEN THE BLADE BEGAN TO WOBBLE. HCP THEN RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13768072 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT DURING FESS SURGERY, CONNECTION FROM THE BLADE IS BROKEN NEAR THE HUB. THERE WAS NO INTERVENTION PERFORMED / PLANNED. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13504806 ↗
• MalfunctionAug 7, 2020Break; Break

  IT WAS REPORTED VIA HEALTH CARE PROFESSIONAL THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE BLADE'S TIP BROKE INTO A SMALL PIECE. THERE WAS NO BROKEN PIECE OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) WITH NO DELAY. THERE WAS NO INTERVENTION PERFORMED/PLANNED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381593 ↗
• MalfunctionMar 16, 2020Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE FUSION BLADE BROKE DURING THE MIDDLE OF THE CASE. THERE WERE FRAGMENTS. THERE WAS NO PATIENT INJURY AND NO DELAYED TIME IN THE CASE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9834270 ↗
• MalfunctionFeb 13, 2020Break; Break

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT A DEVICE BLADE CAME APART WHEN SEEDING IN HANDPIECE DURING SINUS SURGERY PROCEDURE. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9705581 ↗
• MalfunctionAug 9, 2019Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT A BLADE TIP WAS BROKEN WHEN IT WAS TAKEN OUT FROM PACKAGING. IT WAS DISCOVERED DURING THE PROCEDURE BEFORE USING ON THE PATIENT'S BODY. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879012 ↗
• MalfunctionJul 31, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) CASE WHEN THE SURGEON BEGAN TO USE THE BLADE THE TIP BROKE OFF AND FELL ONTO THE FLOOR. THE SITE OPENED A NEW BLADE AND CONTINUED THE CASE. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8845910 ↗
• MalfunctionJun 24, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE BROKE APART WHILE BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) IN REMOVING POLYPS. THEY OPENED A NEW BLADE AND CONTINUED WITH THE PROCEDURE. THE DEVICE WAS NOT REPROCESSED AND WAS USED FOR THE FIRST TIME. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8726530 ↗
• MalfunctionJun 5, 2019Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE POPPED OFF DURING A SINUS SURGERY. THE DEVICE WAS REPLACED WITH ANOTHER BLADE FROM THE SAME BATCH AND IT POPPED OFF AS WELL. THE FIRST ONE WAS USED ON PATIENT BUT THE SECOND ONE WAS NOT. IT WAS NOTED THAT THERE WAS NO BROKEN PIECES LEFT INSIDE THE PATIENT'S BODY. THERE WAS NO INTERVENTION PLANNED OR PERFORMED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670439 ↗
• MalfunctionJun 5, 2019Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE POPPED OFF DURING A SINUS SURGERY. THE DEVICE WAS REPLACED WITH ANOTHER BLADE FROM THE SAME BATCH AND IT POPPED OFF AS WELL. THE FIRST ONE WAS USED ON PATIENT BUT THE SECOND ONE WAS NOT. IT WAS NOTED THAT THERE WAS NO BROKEN PIECES LEFT INSIDE THE PATIENT'S BODY. THERE WAS NO INTERVENTION PLANNED OR PERFORMED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670312 ↗
• 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 8619948 ↗
• InjuryApr 22, 2019Material Separation; Obstruction of Flow; Material Separation; Obstruction of Flow

  A HEALTH CARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, A BLADE KEPT GETTING CLOGGED AND WAS CLEARED MULTIPLE TIMES WITH A STYLET. THE SURGEON REMOVED TIP AND INSERTED STYLET FROM HIND END TO CLEAR BLADE. THE BLADE WAS REPLACED ON THE HANDPIECE AND USED IN THE RIGHT NASAL CAVITY. BLADE STOPPED WORKING AND UPON REMOVAL IT WAS NOTICED THAT THE TIP WAS MISSING AND A SPRING WAS SHOWING. THE SURGEON USED A 30 DEGREE SCOPE TO LOCATE THE BLADE TIP COVER IN THE CAVITY. AN X-RAY CONFIRMED ABSENCE OF ANY FOREIGN BODIES. THERE WAS A DELAY IN THE SURGICAL PROCEDURE OF LESS THAN 1 HOUR.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8537494 ↗
• MalfunctionMar 20, 2019Material Separation; Material Separation

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE BROKE OFF DURING THE PROCEDURE. THERE WERE NO FRAGMENTS THAT FELL ON THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE AS ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436537 ↗
• MalfunctionFeb 25, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SHAVER CAME APART. UPON FOLLOW-UP IT WAS CONFIRMED THAT THE EVENT OCCURRED INTRAOPERATIVELY. THE CASE WAS COMPLETED USING A NEW BLADE. THERE WERE NO FRAGMENTS OF THE BLADE LEFT IN THE PATIENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8368155 ↗

Other Medtronic Xomed, Inc. products

• NIM Vital9 models · 1,696 reports · 4 recalls
• NIM-Response13 models · 974 reports
• Indigo6 models · 916 reports
• NIM TriVantage18 models · 541 reports · 2 recalls
• StraightShot6 models · 546 reports
• NIM15 models · 410 reports · 2 recalls
• ViSAO16 models · 412 reports
• XPS Straightshot2 models · 356 reports