EverFlex™ Protégé™ EverFlex™ PRB35-06-040-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684059883), received between Jun 30, 2020 and Nov 27, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE PROTÉGÉ EVERFLEX SELF-EXPANDING STENT DURING PROCEDURE TO TREAT A CALCIFIED LESION IN THE PATIENTS PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). NO VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THE LESION WAS PRE-DILATED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. IT IS REPORTED THE SHEATH BROKE INTO SEVERAL PARTS AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING OTHER DEVICES TO RETRIEVE THE PIECES THAT HAD BROKEN OFF THE SHEATH. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15867181 ↗
• MalfunctionJun 30, 2020Premature Activation; Difficult to Remove; Activation, Positioning or Separation Problem; Positioning Problem; Premature Activation; Difficult to Remove; Activation, Positioning or Separation Problem; Positioning Problem

  PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EF ALONG WITH NON-MEDTRONIC SHEATH AND 0.035" GUIDE WIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY, POSTERIOR TIBIAL ARTERY AND ANTERIOR TIBIAL ARTERY. THERE WAS NO DAMAGE NOTED ON THE DEVICE PACKAGING. THE LESION WAS PRE DILATED WITH A 3.0 DEVICE. THERE WAS NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. REMOVAL DIFFICULTIES OCCURRED, THERE WAS DIFFICULTY REMOVING DEVICE PRIOR TO STENT DEPLOYMENT. THE DELIVERY CATHETER CAUGHT ON STENT UPON WITHDRAWAL. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY IMPLANTED STENT. THERE WAS RESISTANCE ENCOUNTERED WHILE ADVANCING THE DEVICE. IT WAS REPORTED THAT ANTEGRADE ACCESS WAS USED AND THE DEVICE WAS ATTEMPTED TO CROSS THE ATA TO BE DEPLOYED IN THE SFA. RESISTANCE WAS FELT AND THE DEVICE WAS PULLED BACK, IT APPEARED TO CATCH ON A NARROW AREA OF THE VESSEL AND OR SHEATH AND PARTIALLY DEPLOYED BEFORE REMOVAL THROUGH SHEATH. THE DEVICE WAS REMOVED AND NO STENT WAS USED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Intimal Dissection; No Consequences Or Impact To Patient

  MAUDE report 10211078 ↗

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