EverFlex™ Protégé™ EverFlex™ PRB35-07-040-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684060056), received between Apr 29, 2020 and Nov 10, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionNov 10, 2023Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A 7X40 PROTÉGÉ EF TO TREAT A CALCIFIED LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION MODERATE. A 6FR 45 CM SHEATHE WAS USED. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/DEPLOYMENT. THERE WAS DIFFICULTY REMOVING THE STENT FOLLOWING STENT DEPLOYMENT. THE DELIVERY CATHETER DID NOT CATCH ON STENT UPON WITHDRAWAL. IT WAS REPORTED THAT A 7X60 PROTÉGÉ WAS PLACED WITH NO ISSUES. POST DILATED WITH NO ISSUES. THE 7X40 PROTÉGÉ STENT WAS PLACED, DELIVERY SYSTEM WOULD NOT COME OUT EASILY. END OF STENT NOT VISUALIZED. PORTION OF STENT FOUND IN ACCESS SHEATH AND REMOVED. THE ENTIRE STENT WAS FULLY REMOVED FROM THE PATIENT. PROCEDURE FINALIZED WITH BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110305 ↗
• MalfunctionApr 29, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  PHYSICIAN INTENDED TO USE A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT WITH A SPIDER FX FOR PATIENT TREATMENT. IFU WAS FOLLOWED. IT IS REPORTED THAT STENT JUMPING OCCURRED IN THE PATIENT'S VASCULATURE. THE DEVICE WAS SAFELY REMOVED. THE PROTÉGÉ STENT WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10008416 ↗

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