EverFlex™ Protégé™ EverFlex™ PRB35-08-030-080Recalls & reported problems
Ev3, Inc · STENT PRB35-08-030-080 PROTEGE EF V07 · Class 3 · Implant
Data updated Oct 13, 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 00821684060193), received between Jun 30, 2023 and Jun 30, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Deformation1
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.
MalfunctionJun 30, 2023Material Deformation; Material Deformation
PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX SELF-EXPANDING STENT DURING PATIENT TREATMENT. EMBOLIC PROTECTION WAS NOT USED. 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. DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT IS REPORTED THE STENT APPEARED LONGER THAN THE LABELLED SIZE ON THE BOX WHEN IT WAS DEPLOYED. THE DEFORMED STENT DEPLOYED IN THE TARGET AREA AND NO ACTION WAS NEEDED AS A RESULT OF THE DEFORMATION. NO STENT PLACEMENT ADJUSTMENT WAS REQUIRED AFTER INITIAL FLOWERING OF THE STENT AND NO FURTHER INTERVENTION WAS NEEDED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17236181 ↗
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™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-060-120Covidien 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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