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EverFlex™ EVD35-07-040-120Recalls & reported problems

Covidien LP · STENT EVD35-07-040-120 EF ENTRUST V01 · Class 3 · Implant

All models of EverFlex (41)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684051429), received between Jun 28, 2017 and Aug 18, 2020 — classified as 2 malfunctions.

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

Device problems

  • Activation, Positioning or Separation Problem2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

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

  • MalfunctionAug 18, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

    PHYSICIAN ATTEMPTED TO IMPLANT AN EVERFLEX ENSTRUST STENT DURING A PROCEDURE. IT IS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND HAD TO BE REMOVED. ANOTHER STENT WAS USED TO COMPETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10418765 ↗
  • MalfunctionJun 28, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

    PHYSICIAN INTENDED TO USE AN EVERFLEX SELF-EXPANDING STENT WITH ENTRUST DELIVERY SYSTEM, USING A 5 FR SHEATH AND .014 GUIDEWIRE FOR THE TREATMENT OF A 35MM MODERATELY TORTUOUS, NON-CALCIFIED PLAQUE LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY OF DIAMETER 7MM WHICH EXHIBITED 70% STENOSIS. DEVICE IFU WAS FOLLOWED AND DEVICE PREPPED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE/DELIVERY TO THE LESION AND EXCESSIVE FORCE WAS REQUIRED. THE STENT WAS BEING DEPLOYED OVER A .014 GUIDEWIRE, WHICH WAS UNSUCCESSFUL AS THE .014 GUIDEWIRE BECAME STUCK ON SYSTEM, STENT FLARED BUT WOULD NOT DEPLOY. THE ENTIRE SYSTEM, WIRE, AND STENT WERE REMOVED WITH RESISTANCE, ULTIMATELY LOSING ACCESS. A SECOND EVERFLEX ENTRUST WAS USED BUT STENT WAS DELIVERED OVER A .035 WIRE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT HAD NO ADVERSE EVENTS AS A RESULT OF THIS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6676147 ↗

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

Other STENT, SUPERFICIAL FEMORAL ARTERY devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page