N/A 9735019Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169443549), received between Apr 9, 2017 and Jan 14, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2020Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A TUMOR RESECTION ( TRANSSPHENOIDAL) PROCEDURE. THE SITE WAS UNABLE TO TRACK THE MALLEABLE SUCTION DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF A SECOND SUCTION. THE REPLACEMENT SUCTION TRACKED WITHOUT ISSUE. THE ISSUE RESULTED IN LESS THAN ONE HOUR PROCEDURE DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9588769 ↗
• MalfunctionApr 4, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE LARGE MALLEABLE SUCTION STOPPED NAVIGATING DURING THE CASE. THERE WAS NO SIGNAL. IT WORKED FOR HALF OF THE CASE THEN ALL OF A SUDDEN IT STOPPED TRACKING. TROUBLESHOOTING INVOLVED THE SITE OPENING A NEW SUCTION AND IT RESOLVED THE PROBLEM. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484325 ↗
• MalfunctionMay 11, 2017Device Stops Intermittently; Communication or Transmission Problem; Device Stops Intermittently; Communication or Transmission Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE MALLEABLE SUCTION WAS UNABLE TO NAVIGATE DURING THE PROCEDURE. THE SITE ELECTED TO USE A SEPARATE MALLEABLE SUCTION TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6560627 ↗
• MalfunctionApr 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT THE MALLEABLE SUCTION BECAME DAMAGED AND UNRESPONSIVE. THE SITE USED ANOTHER MALLEABLE SUCTION TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS A FEW MINUTES. SURGERY PROCEEDED AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6474669 ↗