N/A 9735015Recalls & reported problems
Medtronic Navigation, Inc. · SUCTION 9735015 MALLEABLE STD TIP 7-FR · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169443501), received between Oct 14, 2016 and Jan 6, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Device Stops Intermittently1
- Imprecision1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2017Imprecision; Material Deformation; Imprecision; Material Deformation
A SITE REPRESENTATIVE, X-RAY TECHNICIAN, REPORTED THAT WHILE IN AN EAR, NOSE & THROAT (ENT) PROCEDURE, THEIR MALLEABLE SUCTION WAS DAMAGED. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON ALLEGED A 1 CENTIMETER INACCURACY OCCURRED. THE MALLEABLE SUCTION WAS APPEARING AS TOO LONG IN THE SOFTWARE. ALL OTHER INSTRUMENTS WERE ACCURATE. THE SURGEON OPTED TO CONTINUE AND 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 6229074 ↗MalfunctionOct 14, 2016Device Stops Intermittently; Device Operates Differently Than Expected; Device Stops Intermittently; Device Operates Differently Than Expected
A SITE REPRESENTATIVE REPORTED THAT DURING AN EAR, NOSE, AND THROAT PROCEDURE, A MALLEABLE SUCTION INSTRUMENT WAS UNABLE TO BE TRACKED BY THE NAVIGATION SYSTEM. THE INSTRUMENT TRACKER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SUCTION AND THE NAVIGATION SYSTEM AFTER A DELAY OF LESS THAN ONE HOUR. THE PATIENT WAS NOT IMPACTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6031585 ↗
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
- Medtronic Navigation 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
- StealthStation 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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