EverFlex™ Protégé™ EverFlex™ PRB35-06-040-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684059876), received between Mar 13, 2023 and Jun 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJun 6, 2023Use of Device Problem; Use of Device Problem

  A PROTÉGÉ EF WAS IMPLANTED FOR THE TREATMENT OF A 30MM CALCIFIED LESION IN THE LEFT PROXIMAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER AND MODERATELY CALCIFIED. THE LESION WAS PRE-DILATED WITH A 5MM DEVICE. A NON MEDTRONIC 6FR SHEATH AND GUIDEWIRE WERE USED. IT WAS REPORTED THE STENT WAS TAKEN FROM THE SHELF AND IMPLANTED IN THE PATIENT WITHOUT REALIZING THE DEVICE WAS EXPIRED. NO ISSUES WITH STENT, OTHER THAN IT WAS EXPIRED. THE PROCEDURE WAS COMPLETED IN A NORMAL FASHION WITH GOOD RESULTS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069907 ↗
• MalfunctionMar 13, 2023Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  A PROTEGE EVERFLEX SELF EXPANDING STENT WAS BEING USED TO TREAT A 20MM SOFT TISSUE LESION WITH 70% STENOSIS IN THE MID RIGHT TIBIAL/POPLITEAL TRUNK. THERE WAS SEVERE TORTUOSITY AND MODERATE CALCIFICATION. THE ARTERY DIAMETER WAS 6MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY, TRANS TIBIAL RETROGRADE FASHION ACCESSING THE ANTERIOR TIBIAL, THE ORIGIN OF THE AT WAS VERY TORTUROUS HAVING DIFFICULTIES TRACKING CATHETERS. A 6FR NON MEDTRONIC SHEATH AND A NON MEDTRONIC GUIDEWIRE WERE USED. NO EMBOLIC PROTECTION WAS USED. THE  LESION WAS PRE DILATED WITH AN EVERCROSS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE, NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE FOLLOWING STENT DEPLOYMENT. STENT CATHETER WAS REMOVED APPLIED SOME FORCE (BY PULLING IT OFF THE WIRE) IN A WAY THAT THE PIN PULL CAME APART REMAINING ON THE WIRE AND LOSING WIRE ACCESS BECAUSE OF THAT REASON. THE PHYSICIAN HAD TO REGAIN WIRE ACCESS IN ORDER TO POST DILATE THE TREATED AREA BUT WAS ABLE TO BE DEPLOYED BUT OFF THE TARGET LESION WITH LIKE 5-7MM DISTALLY TO THE TARGET LESION WHICH AFTER POSTDIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529846 ↗

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