EverFlex™ Protégé™ EverFlex™ PRB35-08-080-080Recalls & reported problems
Ev3, Inc · STENT PRB35-08-080-080 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 00821684060254), received between Jan 31, 2023 and Jan 31, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
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.
MalfunctionJan 31, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
A PHYSICIAN WAS IMPLANTING A PROTÉGÉ EF FOR THE TREATMENT OF AN UNKNOWN LESION. IT WAS REPORTED THAT THE DEVICE WAS INSERTED INTO PATIENT. THE STENT WAS POSITIONED AND DEPLOYMENT STARTED. STENT WAS REPOSITIONED, UNDER X-RAY, PRIOR TO FULL DEPLOYMENT. ON REMOVAL OF STENT DELIVERY SYSTEM, PART OF STENT REMAINED ATTACHED TO DELIVERY SYSTEM INDICATING A FRACTURE OR BREAK IN THE STENT. POST DEPLOYMENT X-RAY SHOWED MAJORITY OF STENT IN PLACE, WITH NO APPARENT FRAGMENTS. NO APPARENT INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16272675 ↗
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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