EverFlex™ Protégé™ EverFlex™ PRB35-06-060-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684059906), received between Aug 23, 2021 and Feb 11, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A PROTÉGÉ EVERFLEX WAS USED TO TREAT THE LEFT SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT. APPROXIMATELY 25 MONTHS POST PROCEDURE PATIENT SUFFERED LEFT SUPERFICIAL FEMORAL ARTERY IN-STENT RE-STENOSIS. DUPLEX US SHOWED LEFT IN-STENT STENOSIS. PATIENT UNDERWENT LEFT ANGIOGRAM WITH LEFT FEMOROPOPLITEAL ATHERECTOMY AND BALLOON ANGIOPLASTY. PATIENT TOLERATED PROCEDURE WELL AND PULSE VOLUME RECORDINGS DEMONSTRATED NORMAL FLOW BILATERALLY. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 24317890 ↗
• MalfunctionDec 4, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A PROTEGE EVERFLEX SELF-EXPANDING STENT TO TREAT A LESION.  EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED WITH NO ISSUES NOTED AND AS PER IFU. THERE WERE NO ISSUES NOTED WHEN REMOVING FROM THE PACKAGING, OR WHEN REMOVING FROM THE DEVICE HOOP/TRAY. IT WAS REPORTED THAT INACCURATE DELIVERY OCCURRED (I.E. STENT DEPLOYED IN UNINTENDED LESION SITE). ANOTHER STENT WAS OPENED AND USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255491 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A PROTEGE EF STENT IMPLANTED. PATENT PROX AND MID SFA STENT. CALCIFIED STENOSIS IN THE HUNTERS CANAL. USED IVUS TO DETERMINE GREATER THAN 50% STENOSIS, USED DIRECTIONAL ATHERECTOMY IN HUNTERS CANAL AND THEN USED 4X120 POST ATHERECTOMY, USED IVUS AGAIN AND SHOWED GREATER THAN 30% STENOSIS SO PLACED 6X60 EVERFLEX STENT IN THE DISTAL SFA/PROX POP; POST DILATED WITH 4X120CM PTA. THE STENT WAS IN GOOD STANDING, HOWEVER THE VESSEL HAD THROMBOSED CAUSING THE PATIENT PAIN IN THEIR LEG WHICH BEGAN HURTING 1 DAY POST PROCEDURE. THE PATIENTS FOOT AND BOTTOM PART OF LEG WAS COLD. FOLLOW UP PROCEDURE APPROXIMATELY 1 WEEK POST INITIAL PROCEDURE WHERE OPENED THE SFA UNTIL 4CM ABOVE THE STENT AND OCCLUDED TO THE BOTTOM OF THE OLD STENT DUE TO THROMBUS. TREATED THE THROMBUS WITH ANJIOJET. POST IVUS STILL SHOWED RESIDUAL CLOT SO USED LASER ATHERECTOMY. POST ANGIOGRAPHY SHOWED A DISSECTION ABOVE THE OLD STENT SO A 6X80 STENT WAS DEPLOYED ABOVE IT AND THEN ANOTHER 6X30 PLACED IN THE AREA BETWEEN THE TWO STENTS.

  Patient problems: Pain; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 16003354 ↗
• MalfunctionAug 23, 2021Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ EVERFLEX STENT WITH A SPIDER FX EMBOLIC PROTECTION DEVICE TO TREAT THE MID SUPERFICIAL FEMORAL ARTERY IN A PATIENT. THE LESION WAS MODERATELY TORTUOUS AND CALCIFIED PLAQUE WITH 50% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS USED. NO DAMAGE WAS NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED. IT IS REPORTED THAT THE STENT FAILED TO CROSS/POSITION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. THE PROCEDURE WAS COMPLETED WITH PRE-DILATION WITH BALLOON AND THE STENT WAS ABLE TO BE DEPLOYED. THE STENT WAS NOT DEPLOYED IN THE TARGET AREA, BUT REPORTED TO BE CLOSE TO THE TARGET. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352356 ↗

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