Protégé™ GPS™ SERB65-10-30-80Recalls & reported problems
Ev3, Inc · STENT SERB65-10-30-80 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 00821684071526), received between Feb 14, 2017 and Feb 14, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
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.
MalfunctionFeb 14, 2017Material Deformation; Material Deformation
PHYSICIAN WAS ATTEMPTING TO TREAT A LESION IN THE LEFT ARM AV FISTULA USING PROTEGE STENT. THE LESION WAS PRE DILATED WITH 8X40 EVERCROSS BALLOON. IT WAS REPORTED THAT THE STENT DEFORMED IN VIVO DURING POSITIONING. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE LESION IS MODERATELY CALCIFIED AND VESSEL MODERATELY TORTUOUS. PHYSICIAN USED SAME SIZE PROTEGE STENT TO COMPLETE PROCEDURE. THERE WAS NO INJURY TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6329155 ↗
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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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