Protégé™ GPS™ SERB65-09-30-120Recalls & reported problems
Ev3, Inc · STENT SERB65-09-30-120 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 00821684071410), received between Oct 15, 2020 and Oct 15, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
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.
MalfunctionOct 15, 2020Use of Device Problem; Use of Device Problem
IT HAS BEEN REPORTED A PROTÉGÉ GPS SELF-EXPANDING STENT HAS BEEN IMPLANTED IN A PATIENT TO TREAT A CRITICAL ISCHEMIA POST EXPIRY OF THE PRODUCT. THERE WAS NO EVENT OR COMPLICATION DURING THE PROCEDURE REPORTED. DURING POST PROCEDURE RECOVERY, THERE WAS NO MEDICAL EVENT OR COMPLICATION REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10683749 ↗
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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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