N/A 961581Recalls & reported problems
Medtronic Navigation, Inc. · ARRAY 961581 SURETRAK2 LARGE PASSIVE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00721902672309), received between Feb 22, 2017 and Aug 13, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 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, 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
- Material Integrity Problem2
- Material Deformation1
- Naturally Worn1
Patient problems
- No Patient Involvement4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A DAMAGED BLACK SURETRAK. THIS WAS DISCOVERED DURING SET-UP AND NO PATIENT WAS PRESENT. THE ORANGE SURTRAK WAS USED INSTEAD.
Patient problems: No Patient Involvement
MAUDE report 8888087 ↗MalfunctionMar 18, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SCREW THREAD OF THE LARGE PASSIVE FIGHTER WAS STRIPPED AND THE PRODUCT COULD NOT BE FIXED TIGHTLY. ANOTHER LARGE PASSIVE FIGHTER WAS USED. THERE WAS NO PATIENT PRESENT.
Patient problems: No Patient Involvement
MAUDE report 8428516 ↗MalfunctionMay 23, 2017Material Deformation; Material Deformation
A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREWS FOR THE INSTRUMENT WERE STRIPPED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Patient problems: No Patient Involvement
MAUDE report 6584271 ↗MalfunctionFeb 22, 2017Naturally Worn; Naturally Worn
A SITE REPRESENTATIVE REPORTED THAT THE BLACK SURETRAK TRACKER HAD A STRIPPED SCREW. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT.
Patient problems: No Patient Involvement
MAUDE report 6350723 ↗
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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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