EverFlex™ EVD35-06-060-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684051351), received between Oct 11, 2017 and Aug 22, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 16, 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.

• MalfunctionAug 22, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG DURING PROCEDURE TO TREAT A LESION IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER AND LESION LENGTH ARE 5.5MM AND 60MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM THE HOOP/TRAY. PARTIAL DEPLOYMENT OCCURRED WITH NO DAMAGE TO DEPLOYMENT MECHANISM OR HANDLE REPORTED PRIOR TO DEPLOYMENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED AT TIME OF DEPLOYMENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE WITH EXCESSIVE FORCE USED DURING DELIVERY. IT WAS REPORTED THAT MANUAL DEPLOYMENT WAS INITIATED. STENT COMPLETELY DEPLOYED BUT WAS ELONGATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264279 ↗
• InjuryJun 14, 2021Premature Activation; Premature Activation

  PHYSICIAN WAS ATTEMPTING TO USE EVERFLEX ENTRUST SUPERFICIAL FEMORAL ARTERY SELF-EXPANDING STENT DURING PROCEDURE. IT WAS REPORTED THAT WHEN ADVANCING STENT OVER GUIDEWIRE, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED. THE RED SAFETY CLIP WHICH PREVENTS DEPLOYMENT WAS STILL IN PLACE. THE EVENT REQUIRED INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 11989719 ↗
• MalfunctionJan 26, 2018Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX SELF-EXPANDING STENT WITH ENTRUST DELIVERY SYSTEM TO TREAT A 40MM MODERATELY CALCIFIED FIBROUS CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE RIGHT DISTAL SFA. THE ARTERY HAD A DIAMETER OF 5 MM AND WAS MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 0.018" NON-MEDTRONIC GUIDEWIRE AND A 6 FR NON-MEDTRONIC SHEATH. THE LESION WAS PRE-DILATED USING A 5X120 PTA BALLOON. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. THE STENT WAS ADVANCED OVER THE GUIDEWIRE AND THE RED SAFETY CORD WAS REMOVED. IT WAS REPORTED THAT WHEN THE PHYSICIAN BEGAN TO DEPLOY BY ROTATING THE DEPLOYMENT WHEEL, CLICKING WAS OBSERVED BUT THE STENT WAS NOT UNSHEATHED. IT WAS REPORTED A "PAPERCLIP" LOOKING SPRING UNDER THE HANDLE WHERE THE SAFETY CORD WAS REMOVED WAS OBSERVED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE OVER THE GUIDEWIRE BUT IT WAS NOT POSSIBLE. THE DEVICE WAS REMOVED ALONG WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED BY RE-WIRING THE LESION AND USING A 6X 40 STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7223288 ↗
• MalfunctionOct 11, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX SELF-EXPANDING STENT WITH ENTRUST DELIVERY SYSTEM TO TREAT A LESION IN THE DISTAL SFA. THE LESION LENGTH WAS 60 MM AND THE ARTERY DIAMETER WAS 5.0 MM. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT'S ANATOMY. NO ISSUES WERE NOTED TO THE DEVICE OR PACKAGING DURING SET UP AND THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS PRE-DILATED USING A 5.0 X 200 PRE-DILATION DEVICE AND A 6 FR SHEATH WAS USED. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN ADVANCING THE DEVICE AND FORCE WAS APPLIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LOCK PIN WAS REMOVED WHEN THE STENT WAS READY TO BE DEPLOYED. THE STENT HAD DIFFICULTY PASSING THROUGH A CALCIFIED AREA PROXIMAL TO THE INTENDED LESION. IT WAS REPORTED THAT WHEN THE PHYSICIAN DID MANAGE TO POSITION THE STENT, THE DEPLOYMENT WHEEL WAS ROTATED BUT THE STENT DID NOT DEPLOY. THE PHYSICIAN STOPPED WHEN THE STENT CATHETER NEXT TO THE DEPLOYMENT HANDLE STARTED TO ACCORDION. THE STENT WAS NOT DEPLOYED AND THE STENT CATHETER WAS STUCK ON THE WIRE. THE STENT CATHETER COULD NOT BE REMOVED ON ITS OWN AND THE STENT AND WIRE H

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6939447 ↗

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