eNV® 9731234Recalls & reported problems
Medtronic Navigation, Inc. · PROBE, 9731234 ENV FRAZIER SUCTION · Class 2
Data updated Oct 18, 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 00885074523217), received between Mar 27, 2017 and Jun 21, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE ENV FRAIZER SUCTION WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.
Patient problems: No Patient Involvement
MAUDE report 8723311 ↗MalfunctionMar 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE OSTIUM SEEKER BECAME DAMAGED DURING SURGERY. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION WITH NO PATIENT IMPACT. NO DELAY IN SURGERY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6435650 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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