EverFlex™ Protégé™ EverFlex™ PRB35-06-100-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684059944), received between Feb 16, 2021 and Oct 7, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 18, 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.

• MalfunctionOct 7, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A PROTEGE EF TO TREAT A LESION. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE-DILATED. IFU WAS NOT FOLLOWED AS IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED IN THE PATIENT. PHYSICIAN REALIZED THIS AFTER CASE. DEVICE REMAINS IMPLANTED. THERE WAS NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20391187 ↗
• MalfunctionFeb 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EF SELF-EXPANDING STENT DEVICE TO TREAT A RIGHT, MID PROXIMAL SUPERFICIAL FEMORAL ARTERY LESION IN A PATIENT. THE LESION WAS CALCIFIED, WITH LITTLE CALCIFICATION AND TORTUOSITY, WITH PLAQUE AND 70% STENOSIS. THE TARGET VESSEL WAS A 6MM VESSEL. THE LESION WAS PREDILATED, THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT PHYSICIAN BELIEVES THE STENT IN THE PACKAGE WAS A 6X120 INSTEAD OF THE 6X100 INDICATED ON THE PACKAGING; THE STENT WAS DEPLOYED AND PLACED WITH NO ISSUES. A NON-MEDTRONIC 6X100 WAS USED BALLOON. THE PHYSICIAN NOTICED THE STENT WAS LONGER THAN ANTICIPATED AND COMPARED IT TO A 6X100 BALLOON. STENT WAS DEPLOYED WITH NO RESISTANCE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332061 ↗

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