EverFlex™ Protégé™ EverFlex™ PRB35-06-080-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684059920), received between Nov 18, 2020 and Mar 25, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionMar 25, 2026Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX FOR TREATMENT OF A CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. A 6FR NON MEDTRONIC SHEATH AND 0.014" NON MEDTRONIC GUIDEWIRE WERE USED. THE VESSEL WAS PRE-DILATED WITH A 5X40 NANOCROSS. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED (AT TARGET SITE) WITHIN THE PATIENT VASCULATURE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT. THE DEVICE WAS SUCCESSFULLY IN TANDEM WITH DELIVERY SYSTEM WITHOUT INJURY/INTERVENTION. ANOTHER EVERFLEX WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY OR INTERVENTION WAS ASSOCIATED WITH THIS EVENT. AN EVERCROSS WAS USED FOR POST-DILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685429 ↗
• InjuryFeb 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PROTEGE EVER FLEX SELF-EXPANDING STENT, A DELIVERY CATHETER COMPONENT DETACHED. THE EVENT OCCURRED IN THE PERIPHERAL ARTERY, SPECIFICALLY THE MID-LOCATION OF THE RIGHT POPLITEAL ARTERY, WHICH WAS CALCIFIED WITH A DIAMETER OF 6MM. THE PROCEDURE WAS COMPLETED USING A SNARE TO RETRIEVE THE DETACHED TIP OF THE DELIVERY CATHETER. THE VESSEL WAS BOTH PRE-DILATED AND POST-DILATED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374191 ↗
• MalfunctionNov 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE PROTEGE EVERFLEXT DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT WHILE DEPLOYING THE STENT, THE PROXIMAL "PULL" SEGMENT DETACHED FROM THE CATHETER. THE BREAK/FRACTURE OCCURRED AT THE HANDLE. NOTHING DETACHED IN THE BODY. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT USING A FIRM GRIP ON THE OUTER SHEATH THAT CONSTRAINS THE STENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10859587 ↗

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