EverFlex™ Protégé™ EverFlex™ PRB35-07-060-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684060063), received between Nov 26, 2020 and Aug 20, 2025 — classified as 2 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO PROTEGE EVERFLEX STENTS WERE USED TO TREAT THE COMMON ILIAC, EXTERNAL ILIAC. PATIENT SUFFERED FULL-THICKNESS ULCERATION OVER THE LATERAL ASPECT OF THE FOREFOOT CENTERED OVER THE METATARSAL HEAD WITH EXPOSED BONE AND KNOWN OSTEOMYELITIS OF THE FIFTH METATARSAL. THE EVENT WAS TREATED WITH RIGHT FIFTH RAY AMPUTATION; IRRIGATION AND SHARP EXCISIONAL DEBRIDEMENT OF RIGHT FOOT SOFT TISSUE INFECTION; ROTATIONAL PEDICLED FLAP, RIGHT FOOT; APPLICATION OF A WOUND VAC TO AN AREA MEASURING 3X2C.  PATIENT RECOVERED/RESOLVED WITH SEQUELAE.

  Patient problems: Ulcer

  MAUDE report 22851190 ↗
• InjuryNov 26, 2020Material Deformation; Material Deformation

  A PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX STENT TO TREAT A CTO LESION IN THE DISTAL LEFT EXTERNAL ILIAC ARTERY REPORTED TO BE CALCIFIED AND WITH PLAQUE. THE TORTUOSITY AND CALCIFICATION WERE MODERATE IN A PATIENT. THE DEVICE WAS PREPPED AS PER IFU, NO DAMAGE NOTED TO PACKAGING, NO ISSUES REMOVING THE DEVICE FROM THE HOOP. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED DURING POSITIONING OF THE STENT. IT WAS REPORTED THAT THE DISTAL END OF THE STENT WOULD NOT OPEN. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO EXCESSIVE FORCE WAS SUED. THE VESSEL WAS OCCLUDED DUE TO THE DEVICE COMPONENT. THE PROCEDURE COMPLETED BY WAS POST DILATING THE DISTAL END OF THE STENT WITH 7 BALLOON AND A SECOND EVERFLEX STENT WAS PLACED INSIDE THE PREVIOUS STENT. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 10911215 ↗

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 · Completed
  Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
• Z-1644-2022 · Jul 14, 2022 · Open, Classified
  EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
• Z-2048-2016 · May 23, 2016 · Terminated
  EV3 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