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EverFlex™ Protégé™ EverFlex™ PRB35-08-040-120Recalls & reported problems

Ev3, Inc · STENT PRB35-08-040-120 PROTEGE EF V07 · Class 3 · Implant

All models of EverFlex Protégé EverFlex (27)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684060223), received between Oct 20, 2020 and Oct 20, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Device problems

  • Device Dislodged or Dislocated1
  • Fracture1

Patient problems

  • Injury1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 20, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

    PHYSICIAN PLACED A PROTÉGÉ RX SELF-EXPANDING STENT DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL, MID, AND DISTAL LEFT COMMON ILIAC ARTERY. MODERATE VESSEL CALCIFICATION AND SLIGHT TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% STENOSIS. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED WITH A 6X40 PRE-DILATION DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. NO ISSUES REPORTED DURING DEPLOYMENT OF THE PROTÉGÉ EVERFLEX. DURING POST-DILATION OF THE PROTÉGÉ EVERFLEX STENT, THE BALLOON IS REPORTED TO HAVE BECOME CAUGHT ON STENT CAUSING THE STENT TO FACTURE. THE STENT IS REPORTED TO HAVE SLID PROXIMALLY INTO THE DISTAL AORTA. THE PHYSICIAN GAINED ACCESS ON THE OTHER SIDE AND DEPLOYED BI-LATERAL VISI-PRO STENTS UTILIZING A "KISSING" STENT TECHNIQUE AT THE BIFURCATION TO STABILIZE THE PROTÉGÉ EVERFLEX STENT. A GOOD RESULT IS REPORTED TO HAVE BEEN ACHIEVED. NO FURTHER INJURY REPORTED. NO ISSUE REPORTED FOR THE VISIPRO STENTS DEPLOYED.

    Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

    MAUDE report 10704453 ↗

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

All STENT, SUPERFICIAL FEMORAL ARTERY devices →

Sources and updates

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