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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684060087), received between Jul 12, 2022 and Jun 5, 2025 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED WITH LIMITED INFORMATION THAT THE PROTEGE EVERFLEX SELF EXPANDING STENT EXPERIENCED STENT DEFORMATION DURING USE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150959 ↗
• InjuryMar 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX SELF-EXPANDING STENT WITH A 6FR NON-MEDTRONIC SHEATH DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN THE PATIENTS RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION WAS REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE AND POST DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THE TIP OF STENT CATHETER BROKE OFF AFTER DEPLOYMENT AND A SNARE WAS USED TO RETRIEVE. THE STENT REMAINS IN THE PATIENT. THERE WAS NO DEFORMATION NOTED TO THE DEPLOYED STENT. A NON-MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948621 ↗
• MalfunctionJul 12, 2022Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT DURING PROCEDURE. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT STENT DEFORMATION IN VIVO DURING POSITIONING/DEPLOYMENT OCCURRED DURING THE PROCEDURE. THE PHYSICIAN STATED THE STENT ELONGATED UPON DEPLOYMENT. THE PHYSICIAN STATED THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14985678 ↗

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