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

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00821684059968), received between Mar 30, 2020 and Nov 7, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SOFT TISSUE, MODERATE TORTUOSITY, 100 MM LENGTH, 6 MM DIAMETER), A DEPLOYMENT ISSUE OCCURRED WITH THE PROTEGE EF, STENT PRE-DEPLOYED ON THE WAY TO THE TARGET SITE IN THE PATIENT. THE STENT WAS NEVER IMPLANTED AND WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE OUTCOMES, OR VESSEL DAMAGE WERE REPORTED. THE VESSEL WAS PRE-DILATED USING AN EVERCROSS DEVICE, AND THE SHEATH AND GUIDEWIRE DETAILS WERE PROVIDED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND NO RESISTANCE OR PACKAGING DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED USING A NEW PROTEGE EVERFLEX DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497090 ↗
• MalfunctionNov 29, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PROTEGE STENT WAS ATTEMPTED TO BE IMPLANTED IN THE COMMON ILIAC ARTERY. THE TYPE OF LESION BEING TREATED, LESION LENGTH, % LESION STENOSIS, DEGREE OF TORTUOSITY AND CALCIFICATION WERE, DISTAL AORTA: MILD SACCULAR ANEURYSM, MODERATELY CALCIFIED. RIGHT CIA: MILD TO MODERATE DIFFUSE DISEASE, MODERATELY CALCIFIED. RIGHT EIA: 80% DIFFUSE DISEASE, SEVERE CALCIFIED. RIGHT IIA: MODERATE TO SEVERE DIFFUSE DISEASE, MODERATELY CALCIFIED. RIGHT CFA: 60-70% DIFFUSE DISEASE, MODERATELY TO SEVERELY CALCIFIED. RIGHT SFA: PROXIMAL SFA CTO, MODERATE SEVERE CALCIFICATION, RECONSTITUTES AT THE MID SFA WITH COLLATERALS FROM THE PROFUNDA FEMORIS. DISTAL SFA MILD TO MODERATE DIFFUSE DISEASE. THE IFU WAS FOLLOWED. THE LESION WAS PRE-DILATED, SHOCKWAVE. IT WAS REPORTED THAT THE STENT COULD NOT BE DEPLOYED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE NOTED DURING ADVANCEMENT. THE LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED TO DEPLOYMENT. THERE WAS A DELAY OF 10 MINUTES AS A RESULT OF THE PRODUCT MALFUNCTION, NO MEDICATIONS OR TREATMENT AS A RESULT OF THE 10-MINUTE PROCEDURE DELAY. THE STENT WAS NOT IMPLANTED AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. STENT STRUTS WERE EX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809346 ↗
• MalfunctionJul 7, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A PROTEGE EF WAS INTENDED TO BE IMPLANTED FOR TREATMENT OF A 120MM PLAQUE LESION WITH CHRONIC TOTAL OCCLUSION IN THE COMMON ILIAC ARTERY. THE ARTERY DIAMETER WAS 5MM WITH MODERATE TORTUOSITY AND CALCIFICATION. A 5/40 NON MEDTRONIC DEVICE WAS USED TO DILATE THE VES SEL, THEN HE USED THE BALLOON TO MEASURE THE LENGTH OF THE VESSEL WHERE STENT NEEDED TO BE PLACED, IT MEASURED APPROXIMATELY 110MM SO A 120MM STENT WAS REQUESTED. UPON PLACING THE STENT IN THE VESSEL THE PHYSICIAN NOTICED THE LENGTH WAS TOO LONG AND REQUESTED A DIFFERENT SIZE STENT. LENGTH OF THE STENT DID NOT MATCH THE LABEL ON THE PACKAGING. LABEL STATES THE STENT IS 120MM, BUT UNDER FLUOR IS LOOKS LIKE A 150MM. THE STENT WAS REMOVED. AN EVERFLEX 6/100/120 STENT WAS PLACED IN VESSEL WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276881 ↗
• InjuryFeb 26, 2021Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE PROTEGE EVERFLEX SELF-EXPANDING STENT ALONG WITH A 7FR SHEATH AND NON-MEDTRONIC 0.035" GLIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS LITTLE TORTUOUS. 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. THERE WAS SUFFICIENT DISTAL LANDING ZONE. DURING DEPLOYMENT, IT APPEARED THE PROXIMAL END OF THE DEPLOYMENT SYSTEM APPEARED TO PROGRESS DISTALLY. THE DELIVERY SYSTEM WAS THEN REPOSITIONED AND THEN THE DELIVERY PROCESS PROCEEDED ON. THE STENT WAS PARTIALLY IN THE VESSEL AND PART OF THE STENT WAS IN THE SHEATH AND PART OF THE STENT BROKE OFF ON THE DELIVERY SYSTEM. THE PATIENT WAS MOVED DOWN TO THE OR. THE PHYSICIAN DID A CUT DOWN TO EXPOSE THE VESSEL. THE REMAINING STENT EXPOSED FROM THE ARTERY WAS THEN CUT OFF. PHYSICIAN WAS ABLE TO REPAIR THE VESSEL WHILE LEAVING PART OF THE STENT STILL IN THE PATIENT. DOPPLER WAS PERFORMED WITH THE GOOD FLOW PROXIMALLY AND DISTALLY OF THE TARGET. PATIENT WAS STABLE AND WAS BEING MOVED TO ICU FOR OBSERVATION. IT WAS REPORTED THAT

  Patient problems: Perforation

  MAUDE report 11385517 ↗
• InjuryNov 20, 2020Physical Resistance/Sticking

  STENT (PROTÉGÉ) IMPLANTED INTO PT'S LEFT ARM AV GRAFT. DURING PROCEDURE, SURGEON NOTICED THAT PART OF THE STENT WAS LODGED IN PT. CUTDOWN ON THE CEPHALIC VEIN NEEDED TO REMOVE STENT INSERTION DEVICE.

  Patient problems: Tissue Damage

  MAUDE report 10876924 ↗
• InjuryMar 30, 2020Difficult to Remove; Difficult to Remove

  PHYSICIAN INTENDED TO SUE A PROTEGE EVERFLEX DURING PATIENT TREATMENT. THE STENT WAS DEPLOYED. DURING REMOVAL OF THE STENT DELIVERY SYSTEM DIFFICULTY WAS ENCOUNTERED. THE PROCEDURE WAS COMPLETED WITH CUTDOWN AND REMOVAL OF THE STENT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 9897431 ↗

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