EverFlex™ Protégé™ EverFlex™ PRB35-07-020-120Recalls & reported problems
Ev3, Inc · STENT PRB35-07-020-120 PROTEGE EF V07 · Class 3 · Implant
All models of EverFlex Protégé EverFlex (27)
Data updated Oct 16, 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 00821684060018), received between Jul 16, 2024 and Jul 16, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
3 other recalls cover devices cleared under the same FDA submission (P110023); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Positioning Problem1
- Premature Activation1
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 16, 2024Premature Activation; Difficult to Advance; Positioning Problem; Premature Activation; Difficult to Advance; Positioning Problem
PHYSICIAN ATTEMPTED TO IMPLANT A PROTÉGÉ EVERFLEX STENT WITH A 45CM 7FR NON-MEDTRONIC SHEATH AND A 014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 12MM CALCIFIED LESION IN THE PATIENT¿S RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY WAS REPORTED. LESION EXHIBITED 40% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE AND POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE AND IT WAS TIGHT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. TRACKING DIFFICULTIES DUE TO PATIENT ANATOMY WAS REPORTED DURING INITIAL ADVANCEMENT. THE GUIDEWIRE WAS HYDRATED AT PREP. THE STENT STARTED TO FLARE ONCE THE DELIVERY DEVICE WAS OUTSIDE OF THE SHEATH AND BEFORE THEY CROSSED THE LESION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19749815 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P110023. One submission often covers many models, so check the product and lot details in each record.
- Z-0623-2024 · Nov 20, 2023 · CompletedProtege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
- Z-1644-2022 · Jul 14, 2022 · Open, ClassifiedEverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
- Z-2048-2016 · May 23, 2016 · TerminatedEV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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