EverFlex™ Protégé™ EverFlex™ PRB35-08-150-120Recalls & reported problems
Ev3, Inc · STENT PRB35-08-150-120 PROTEGE EF V07 · Class 3 · Implant
All models of EverFlex Protégé EverFlex (27)
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 00821684060322), received between Feb 16, 2026 and Feb 16, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Detachment of Device or Device Component1
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.
MalfunctionFeb 16, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY USING THE STENT PR B35-08-150-120 PROTEGE EF V10 AND STENT PRB35-07-150-120 PROTEGE EF V10, THERE WERE DEPLOYMENT ISSUES. THE FIRST STENT COULD NOT BE DEPLOYED, AND THE HANDLE BROKE DURING THE ATTEMPTED DEPLOYMENT. WHEN A SECOND STENT WAS USED, THERE WAS DIFFICULTY DEPLOYING IT AS WELL. BOTH DEVICES WERE SAFELY REMOVED WITHOUT EXPOSING ANY STENT STRUTS OR REQUIRING INTERVENTION FOR REMOVAL. THE VESSEL WAS PRE-DILATED WITH A 4/80 NANO DEVICE AND POST-DILATED WITH A 6/120 PACIFIC PLUS DEVICE. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, INFECTIONS, DEATHS, OR IRREGULARITIES WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24342945 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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