N/A 961578Recalls & reported problems
Medtronic Navigation, Inc. · CLAMP 961578 SURETRAK2 MEDIUM · Class 2
Data updated Oct 16, 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 00721902672279), received between Dec 2, 2016 and Dec 2, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.
Most reported problems
Device problems
- Material Deformation2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2016Material Deformation; Material Deformation
A SITE PURCHASING DEPARTMENT REPRESENTATIVE REPORTED THAT THEIR SURETRAK2 MEDIUM CLAMP WAS DAMAGED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Patient problems: No Patient Involvement
MAUDE report 6141240 ↗MalfunctionDec 2, 2016Material Deformation; Material Deformation
A SITE PURCHASING DEPARTMENT REPRESENTATIVE REPORTED THAT THEIR SURETRAK2 MEDIUM CLAMP WAS DAMAGED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Patient problems: No Patient Involvement
MAUDE report 6141157 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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