Protégé™ GPS™ SERB65-09-40-80Recalls & reported problems
Ev3, Inc · STENT SERB65-09-40-80 PROTEGE GPS V05 · Class 3 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684071441), received between Dec 21, 2016 and Dec 21, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Inaccurate Delivery” (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
- Inaccurate Delivery1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2016Inaccurate Delivery; Inaccurate Delivery
THE PHYSICIAN USED THE PROTÉGÉ GPS 9X40 TO TREAT A LESION IN THE GREAT SAPHENOUS VEIN WITH 90% STENOSIS AS PER IFU. IT WAS REPORTED THE STENT WAS ADVANCED WITH NO RESISTANCE NOTED; THE STENT JUMPED AND MISSED THE TARGET LESION. THE PHYSICIAN USED A 9X60X120 TO EXTEND THE STENT, TO COVER THE LESION. THE PROCEDURE WAS SUCCESSFUL WITH NO ISSUES NOTED. NO ISSUES WITH EITHER SIDE OF THE STENTS. THE EXTENSION WAS ACCEPTABLE WITH NO NEGATIVE OUTCOMES TO THE PATIENT. NO FURTHER CLINICAL SEQUELAE REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6192934 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Absolute Pro 1012536-100Abbott Vascular Inc. · STENT, ILIAC21 reports
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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