EverFlex™ Protégé™ EverFlex™ PRB35-07-120-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684060131), received between Nov 30, 2018 and Aug 14, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

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 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A VISI PRO STENT AND A PROTÉGÉ EVERFLEX STENT WERE USED TO TREAT THE LEFT COMMON ILIAC, EXTERNAL ILIAC. APPROXIMATELY 11 MONTHS POST PROCEDURE PATIENT SUFFERED RESTENOSIS WITHIN THE DISTAL EXTERNAL ILIAC/COMMON FEMORAL VESSELS. FROM LAST FOLLOW UP, PATIENT COMPLAINED OF BILATERAL HIP PAIN AND ANKLE BRACHIAL INDEX DROPPED BILATERALLY. WENT TO OPERATION ROOM FOR LEFT FEMORAL POPLITEAL BYPASS, BALLOON ANGIOPLASTY OF LEFT EXTERNAL ILIAC ARTERY (TARGET LESION) STENTS DUE TO RESTENOSIS. PATIENT RECOVERED.

  Patient problems: Pain; Stenosis

  MAUDE report 22804747 ↗
• InjuryNov 30, 2018Fracture; Fracture

  THE PHYSICIAN INTENDED TO USE THE PROTÉGÉ EVERFLEX 7X120 WITH A NON-MEDTRONIC 6FR SHEATH AND A NON-MEDTRONIC GUIDEWIRE TO TREAT A MODERATELY CALCIFIED FIBROUS 95% STENOSED LESION IN THE LEFT DISTAL COMMON ILIAC ARTERY. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. ARTERY DIAMETER 6MM, LESION LENGTH 120MM, THE LESION WAS NOT PRE-DILATED, NO RESISTANCE OR EXCESSIVE FORCE WAS USED. IT WAS REPORTED THE STENT FRACTURED DURING DEPLOYMENT AT THE LESION SITE, 1/3 OF THE STENT REMAINS IN THE PATIENT THE REMAINING STENT WAS REMOVED FROM THE PATIENT WITHIN THE CATHETER HOUSING. ANOTHER PROTÉGÉ EVERFLEX 7X80 WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8119481 ↗

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