EverFlex™ Protégé™ EverFlex™ PRB35-06-020-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684059845), received between Nov 9, 2020 and May 30, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A 100% STENOSED, MODERATELY CALCIFIED, 20 MM PLAQUE LESION IN THE RIGHT PROXIMAL PO PLITEAL ARTERY USING THE PROTEGE EVERFLEX, THERE WAS A DEPLOYMENT ISSUE. THE ARTERY WAS 6MM IN DIAMETER WITH MINIMAL TORTUOSITY. THERE WAS NO RESISTANCE DURING ADVANCEMENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. DEPLOYMENT ISSUES WERE ENCOUNTERED, THE PROXIMAL CATHETER SEPARATED FROM THE DELIVERY HUB, EXPOSING THE TUBE AND PREVENTING DEPLOYMENT, WHICH CAUSED A FIVE-MINUTE DELAY IN SURGERY. THE PHYSICIAN MANUALLY PULLED THE HYPO TUBE FROM INSIDE THE CATHETER TO DEPLOY THE STENT, BREAKING THE MID PIN AND PULL DEPLOYMENT. THE VESSEL WAS PRE-DILATED WITH A 4X80 DRUG COATED BALLOON, AND A 6X45 NON MEDTRONIC SHEATH AND NON MEDTRONIC GUIDEWIRE WERE USED. THE STENT WAS SUCCESSFULLY DEPLOYED WITHOUT INJURY OR INTERVENTION, AND THE DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114392 ↗
• MalfunctionNov 9, 2020Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A PROTEGE EVERFLEX SELF-EXPANDING STENT DURING A FISTULA MAINTENANCE PROCEDURE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT THE STENT PARTIALLY DISLODGED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED OVER THE WIRE. NO STENT WAS USED TO REPLACE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10809079 ↗

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