EverFlex™ Protégé™ EverFlex™ PRB35-07-200-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684060162), received between Feb 24, 2021 and Mar 11, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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.

• InjuryMar 11, 2026Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF PLAQUE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (PROXIMAL AND MID SEGMENTS, LESION LENGTH GREATER THAN 190MM, ARTERY DIAMETER 6MM) WITH THE PROTEGE EF V10, STENT DEFORMATION WAS OBSERVED IN THE LATE STAGES OF DEPLOYMENT. THE STENT/STRUTS WERE DEFORMED IN VIVO, AND THE STENT ACCORDIONED. A KINK WAS NOTED IN THE PROXIMAL STENT DURING THE PROCEDURE. THE STENT WAS SURGICALLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573974 ↗
• MalfunctionMar 9, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE PROTÉGÉ EVERFLEX SELF-EXPANDING STENT DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS MODERATELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THERE WAS DIFFICULTY REMOVING DEVICE FOLLOWING STENT DEPLOYMENT. THE DELIVERY CATHETER CAUGHT ON STENT UPON WITHDRAWAL. THE LESION WAS NOT PRE DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE MAKE AND MODEL OF THE PREVIOUSLY DEPLOYED STENT IS UNKNOWN. THE STENT WAS DEPLOYED AND DURING RETRIEVAL PROCESS, THE DETACHMENT WAS NOTICED ON THE GUIDEWIRE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13707109 ↗
• MalfunctionFeb 24, 2021Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE PROTÉGÉ EVERFLEX SELF-EXPANDING STENT TO TREAT A MID-SUPERFICIAL FEMORAL ARTERY LESION IN A PATIENT. THE LESION HAD LITTLE CALCIFICATION AND MODERATE TORTUOSITY, WITH PLAQUE AND 70% STENOSIS. IFU WAS FOLLOWED TO PREP THE DEVICE. A NON-MEDTRONIC SHEATH AND GUIDEWIRE WERE USED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE THROUGH THE SHEATH AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THE STENT DISLODGED AND PARTIALLY DEPLOYED AFTER REMOVAL FROM THE PATIENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM WIRE AND IT IS REPORTED THAT IT WAS PARTIALLY FLOWERED. DISLODGMENT HAPPENED DURING THE ATTEMPTED DELIVERY. THE DEVICE NEVER LEFT THE SHEATH OR ENTERED THE PATIENT. THE LOCK PIN WAS SECURE AND INTACT. ANOTHER STENT WAS OPENED AND WAS SUCCESSFULLY DEPLOYED IN THE PATIENT. THERE WERE NO ISSUES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371361 ↗

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