N/A 9735017Recalls & reported problems
Medtronic Navigation, Inc. · SUCTION 9735017 MALLEABLE ANGLE TIP 9-FR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169443525), received between Dec 6, 2016 and Dec 6, 2016 — classified as 1 malfunction.
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
Device problems
- Communication or Transmission Problem1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2016Communication or Transmission Problem; Material Deformation; Communication or Transmission Problem; Material Deformation
A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A EAR, NOSE & THROAT (ENT) PROCEDURE, MALLEABLE SUCTION VERIFICATION ISSUE. THE INSTRUMENT WAS FUNCTIONING NORMALLY, HOWEVER,UNEXPECTEDLY STOPPED TRACKING. ANOTHER MALLEABLE SUCTION WAS OPENED AND WAS USED TO CONTINUE THE PROCEDURE WITHOUT ISSUE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6149838 ↗
Other Ear, Nose, and Throat Stereotaxic Instrument devices
- TruDi NAV Suction TDNS000ZAcclarent, Inc. · Ear, Nose, and Throat Stereotaxic Instrument1 recall61 reports
- Scopis 8000-021-002Stryker Leibinger GmbH & Co. KG · Ear, Nose, and Throat Stereotaxic Instrument1 recall19 reports
- FUSION Compact ™ 9735602Medtronic Navigation, Inc. · Ear, Nose, and Throat Stereotaxic Instrument64 reports
- TruDi™ Navigation System 1Biosense Webster (Israel) Ltd. · Ear, Nose, and Throat Stereotaxic Instrument1 recall14 reports
- StealthStation 9735762Medtronic Navigation, Inc. · Ear, Nose, and Throat Stereotaxic Instrument1 recall0 reports
- StealthStation Cranial Software 9735762Medtronic Navigation, Inc. · Ear, Nose, and Throat Stereotaxic Instrument1 recall0 reports
- Medtronic Navigation 9735762Medtronic Navigation, Inc. · Ear, Nose, and Throat Stereotaxic Instrument1 recall0 reports
- Scopis ENT 8000-020-002Stryker Leibinger GmbH & Co. KG · Ear, Nose, and Throat Stereotaxic Instrument33 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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