EverFlex™ Protégé™ EverFlex™ PRB35-07-060-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684060070), received between Aug 11, 2022 and Apr 7, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Premature Activation

  IT WAS REPORTED THAT, DURING AN ATTEMPTED PERIPHERAL ARTERY STENTING PROCEDURE INVOLVING A CALCIFIED TARGET LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (MID SEGMENT), A PROTEGE EVERFLEX STENT HAD A DEPLOYMENT ISSUE DESCRIBED AS PRE-DEPLOYMENT WHILE ON THE WAY TO THE TARGET SITE IN THE PATIENT. THE TARGET LESION WAS DESCRIBED AS SEVERELY CALCIFIED WITH 80% STENOSIS, A LESION LENGTH OF 40 MM, MINIMAL TORTUOSITY, AND AN ARTERY DIAMETER OF 6.5 MM. A 6F TERUMO DESTINATION SHEATH AND A TERUMO RUN THROUGH GUIDEWIRE WERE USED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE VESSEL WAS NOT PRE-DILATED OR POST-DILATED. THE STENT DID NOT REMAIN IN THE PATIENT AND WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION, AND NO VESSEL DAMAGE WAS REPORTED. THE PROCEDURE WAS COMPLETED USING A NEW PROTEGE EVERFLEX 7×60 DEVICE, AND THE PATIENT WAS REPORTED ALIVE WITH NO INJURY AND NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798425 ↗
• MalfunctionNov 27, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A STENT PRB35-07-060-120 PROTEGE EF V10 WAS USED DURING TREATMENT OF A SOFT TISSUE LESION WITH DISSECTION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (PROXIMAL LOCATION). THE LESION MEASURED 50MM IN LENGTH WITH AN ARTERY DIAMETER OF 6MM AND WAS C HARACTERIZED BY MINIMAL TORTUOSITY AND MINIMAL CALCIFICATION. A 6FR 45CM TERUMO DESTINATION WAS USED. A TERUMO 260CM ADVANTAGE WAS USED. VESSEL WAS PRE-DILATED WITH 6 X 200 EVERCROSS. VESSEL WAS POST-DILATED. MEASURED LESION WITH 7X60 BALLOON, DOCTOR REQUESTED 7 X 60 STENT, 7 X60X 120 EVERFLEX STENT WAS VERIFIED WITH SCRUB TECH AND GIVEN TO SCRUB TECH. STENT WAS PREPPED PER IFU AND ADVANCED TO LESION SITE TO EXTEND PREVIOUSLY DEPLOYED STENT AND DEPLOYED. PHYSICIAN NOTED THAT DEVICE DIDN'T LOOK LIKE A 60MM STENT. PUT IN THE 7 X 60 BALLOON TO COMPARE LENGTH OF BALLOON TO STENT LENGTH. UPON COMPARISON OF THE BALLOON WITH THE STENT THE PHYSICIAN SAID THE STENT CANNOT BE 60MM. STENT DEPLOYED WITHOUT ANY ISSUES. PHYSICIAN WOULD HAVE PREFERRED THE 60MM STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665651 ↗
• MalfunctionAug 11, 2022Material Deformation; Material Deformation

  A PROTEGE SELF-EXPANDING STENT WAS IMPLANTED FOR TREATMENT OF A CALCIFIED LESION IN THE RIGHT DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY HAD MODERATE TORTUOSITY AND CALCIFICATION. THE DEVICE WAS USED WITH A 6 FR NON-MDT SHEATH AND .014 NON-MDT GUIDEWIRE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NOT ISSUES NOTED. IT WAS REPORTED DURING POSITIONING/DEPLOYMENT OF THE DEVICE, STENT DEFORMATION OCCURRED; POST DEPLOYMENT, THE PROXIMAL END IOF THE STENT WAS REPORTED TO BE 'QUITE MANGLED'. THE PROCEDURE WAS COMPLETED WITH BALLOON DILATION. NO PATIENT INJURY WAS REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209367 ↗

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