EverFlex™ Protégé™ EverFlex™ PRB35-07-080-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684060094), received between Apr 25, 2019 and Jul 4, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A PROTEGE EVERFLEX STENT WAS USED TO TREAT THE COMMON ILIAC, EXTERNAL ILIAC ((B)(6) 2024). PATIENT SUFFERED FULL-THICKNESS ULCERATION OVER THE LATERAL ASPECT OF THE FOREFOOT CENTERED OVER THE METATARSAL HEAD WITH EXPOSED BONE AND KNOWN OSTEOMYELITIS OF THE FIFTH METATARSAL ((B)(6) 2024). THE EVENT WAS TREATED WITH RIGHT FIFTH RAY AMPUTATION; IRRIGATION AND SHARP EXCISIONAL DEBRIDEMENT OF RIGHT FOOT SOFT TISSUE INFECTION; ROTATIONAL PEDICLED FLAP, RIGHT FOOT; APPLICATION OF A WOUND VAC TO AN AREA MEASURING 3X2C. PATIENT RECOVERED/RESOLVED WITH SEQUELAE.

  Patient problems: Ulcer

  MAUDE report 19675281 ↗
• MalfunctionApr 25, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE A PROTEGE EVERFLEX TO TREAT A 80MM CALCIFIED PLAQUE LESION IN THE MID RIGHT COMMON FEMORAL ARTERY. ARTERY DIAMETER WAS 6MM. A 6FR SHEATH AND A NON MEDTRONIC 0.035 GUIDEWIRE WAS USED IN THE PROCEDURE. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE HAD PASSED THROUGH A PREVIOUSLY DEPLOYED STENT BUT THERE WAS NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT OR DEPLOYMENT OF THE DEVICE. IT WAS REPORTED THAT AFTER STENT DEPLOYMENT A FRACTURE OCCURRED IN THE MIDDLE OF THE STENT. SOME OF THE STENT DEPLOYED CORRECTLY. RESISTANCE WAS ENCOUNTERED WHEN THE STENT CATHETER WAS REMOVED TO THE HUB OF THE SHEATH AND IT WAS VERIFIED BY X-RAY THAT A PORTION OF THE FRACTURED STENT REMAINED IN THE SHEATH. THE POTION OF THE STENT THAT REMAINED IN THE SHEATH WAS REMOVED MANUALLY IN TANDEM WITH THE SHEATH HUB. THE PORTION OF THE STENT THAT WAS DEPLOYED IN THE VESSEL WAS BALLOONED WITH A 7X80 EVERCROSS WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8549537 ↗

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