Protégé™ GPS™ SERB65-10-40-80 (UDI 00821684071540)Recalls & reported problems
Ev3, Inc · STENT SERB65-10-40-80 PROTEGE GPS V05 · Class 2 · Implant
All models of Protégé GPS (26)
Data updated Oct 18, 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 00821684071540), received between Jun 1, 2017 and Jun 1, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionJun 1, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN WAS ATTEMPTING TO USE ONE PROTÉGÉ GPS STENT. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES NOTED. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, A BREAK/FRACTURE OCCURRED AT THE HANDLE. THE BREAK OCCURRED OUTSIDE OF THE PATIENT. THE UNDEPLOYABLE STENT WAS REMOVED AND ANOTHER STENT PLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6606713 ↗
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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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