EverFlex™ EVD35-08-120-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684051542), received between Jan 31, 2019 and Mar 1, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• MalfunctionMar 1, 2021Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE EVERFLEX ENTRUST SELF-EXPANDING STENT DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT POPLITEAL ARTERY. THE VESSEL WAS SEVERELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DEPLOYMENT ISSUE OCCURRED. THE DEPLOYMENT WHEEL CRACKED AND WAS UNABLE TO COMPLETE DELIVERY USING THUMB WHEEL. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT DEPLOYED HALFWAY BEFORE THE THUMB WHEEL CRACKED. FOLLOWING THUMB WHEEL BREAK, THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PATIENT OVER THE WIRE. AS THE SYSTEM WAS WITHDRAWN, THE STENT DELIVERED WHERE THE PHYSICIAN INTENDED. ENOUGH PURCHASE WAS MADE BY THE STENT ON THE VESSEL WALL THAT IT SELF-DEPLOYED THE REST OF THE WAY. NO MANUAL DEPLOYMENT METHOD WAS USED. PHYSICIAN MENTIONED RESISTANCE DELIVERING THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391292 ↗
• InjuryJan 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST TO TREAT A 120MM MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE RIGHT PROXIMAL, MID AND DISTAL EXTERNAL ILIAC OF DIAMETER 7MM. A 6FR TERUMO SHEATH AND AN 0.035 GUIDEWIRE WAS USED. NO EMBOLIC PROTECTION WAS USED. THE LESION WAS NOT PRE-DILATED. THE DEVICE WAS PREPPED WITH NO ISSUES. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE STENT SEEMED TO PUSH OUT FROM THE DISTAL MARK RATHER THAN THE OUTER SHEATH RETRACTING OVER THE CATHETER. THE STENT WAS DEPLOYED INCORRECTLY AND REMAINS IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8292228 ↗

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