Protégé™ GPS™ SERB65-09-20-120 (UDI 00643169728905)Recalls & reported problems
Ev3, Inc · STENT SERB65-09-20-120 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169728905), received between Jul 10, 2023 and Jul 10, 2023 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- Local Reaction1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2023Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT CONTACTED MEDTRONIC TO FIND OUT WHAT METALS ARE IN THE PROTÉGÉ GPS STENT. PATIENT EXPRESSED THAT SHE HAD A PROTÉGÉ GPS STENT IMPLANTED BUT SHE DID NOT TELL THE IMPLANTING PHYSICIAN THAT SHE IS ALLERGIC TO NICKEL. THE PATIENT EXPRESSED THAT SHE HAS A RASH ALL OVER HER BODY.
Patient problems: Local Reaction; Rash
MAUDE report 17286463 ↗
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