EverFlex™ Protégé™ EverFlex™ PRB35-08-060-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684060247), received between Jul 24, 2023 and Mar 5, 2026 — classified as 2 injuries, 1 malfunction.

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 5, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE EP SPD2-US-050-320 SPIDER FX DEVICE, A PATIENT EXPERIENCED A 30-MINUTE DELAY IN SURGERY DUE TO A PRODUCT MALFUNCTION. THE PROCEDURE TARGETED A 100% STENOSED LESION WITH PLAQUE LOCATED IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, WITH A LESION LENGTH OF 200MM AND ARTERY DIAMETER OF 7MM. MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. A 7X40 NON-MEDTRONIC SHEATH WAS USED. THE VESSEL WAS POST-DILATED WITH A 6X80 EVERCROSS PTA BALLOON. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. REMOVAL DIFFICULTIES WERE ENCOUNTERED WHEN RETRIEVING THE DEVICE. THE DISTAL PART OF SPIDER DETACHED AND REMAINS OF THE PRODUCT WERE LEFT ON THE STENT. THE DEPLOYED STENT WAS ALTERED AND CORRECTED BY STENT OVERLAP AND PTA. THE DEPLOYED STENT WAS AN 8X60 PROTEGE EVERFLEX STENT. THE RESIDUAL MATERIAL/ENDO-TRASH WAS STENTED OVER AND THE PROCEDURE WAS COMPLETED. NO VESSEL DAMAGE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517647 ↗
• InjuryFeb 16, 2026Fracture

  IT WAS REPORTED THAT THE STENT PRB35-08-060-120 PROTEGE EF V10 FRACTURED DURING A PROCEDURE. THE PHYSICIAN SNARED OUT THE FRACTURED STENT AND USED ANOTHER STENT ON THAT AREA THAT NEEDED STENTED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24349371 ↗
• MalfunctionJul 24, 2023Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT A PROTÉGÉ EF FOR TREATMENT OF A PLAQUE LESION WITH 85% STENOSIS IN THE PROXIMAL REGION OF THE COMMON ILIAC ARTERY. THERE WAS MODERATE TORTUOSITY AND MILD CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. STENT DEFORMATION IN VIVO DURING POSITIONING/DEPLOYMENT IS REPORTED. THE STENT GOT STUCK ON THE SHEATH AND WHEN TRYING TO REMOVE IT STARTED TO DEPLOY AND STENT DEFORMATION OCCURRED. ANOTHER PROTÉGÉ EVERFLEX WAS USED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378382 ↗

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