Protégé™ GPS™ SERB65-10-20-80Recalls & reported problems
Ev3, Inc · STENT SERB65-10-20-80 PROTEGE GPS V06 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169729018), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (P060001); they may or may not involve this specific model.
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 Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2022Use of Device Problem; Use of Device Problem
A PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT WAS IMPLANTED FOR TREATMENT OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE IFU WAS FOLLOWED AND NO ISSUES WERE NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT AFTER THE STENT WAS IMPLANTED IT WAS NOTED THAT THE DEVICE WAS EXPIRED. THERE WAS NO PATIENT INJURY REPORTED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15122483 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P060001. One submission often covers many models, so check the product and lot details in each record.
- Z-0879-2015 · Dec 4, 2014 · Terminatedev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterect
- Z-0878-2015 · Dec 4, 2014 · Terminatedev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endartere
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.
How reports and recalls are matched · Editorial policy · Report an error on this page