EverFlex™ EVD35-08-040-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821684051504), received between Oct 20, 2022 and Mar 11, 2026 — classified as 3 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Component Missing

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE RIGHT DISTAL COMMON ILIAC ARTERY WITH THE EVERFLEX ENTRUST 8X40X120 STENT, THE STENT WAS NOT VISIBLE ON FLUOROSCOPY AND APPEARED TO BE MISSING. THE SYSTEM WAS INSERTED WITH THE RED LOCKING PIN STILL IN PLACE ACCORDING TO INSTRUCTIONS FOR USE, AND THE PHYSICIAN ATTEMPTED STENT DEPLOYMENT WITHOUT VISUALIZATION. MULTIPLE PRIOR STENTS WERE PRESENT IN THE VESSEL, WHICH MADE VISUALIZATION DIFFICULT. FLUOROSCOPY WAS USED TO ATTEMPT VISUALIZATION OF THE STENT. THE VESSEL WAS PRE-DILATED WITH A BOSTON DEVICE, AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO DAMAGE WAS NOTED TO PACKAGING OR DURING REMOVAL FROM THE TRAY. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. ANOTHER IDENTICAL STENT WAS DEPLOYED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566704 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A VISI-PRO STENT AND A EVERFLEX ENTRUST STENT WAS USED TO TREAT THE COMMON ILIAC, EXTERNAL ILIAC. APPROXIMATELY 7 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL RIGHT LIMB ISCHEMIA. PATIENT PRESENTED WITH RESTING ANKLE-BRACHIAL INDEX (ABI) OF 0.4 ON THE RIGHT WITH WORSENING SYMPTOMS OF ISCHEMIA. PATIENT UNDERWENT ANGIOPLASTY AND STENTING WITH A MEDTRONIC STENT TO THE TARGET LESION. PATIENT RECOVERED.

  Patient problems: Ischemia

  MAUDE report 21761595 ↗
• InjuryOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT DURING TREATMENT OF THE PATIENTS PROXIMAL PERONEAL ARTERY. 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) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. TIP DETACHMENT DURING USE IN THE PATIENT WAS REPORTED. IT WAS REPORTED A PORTION OF THE PLASTIC ON THE DISTAL END OF THE STENT DEPLOYMENT SYSTEM BROKE OFF AND INTERVENTION WAS REQUIRED. THE STENT WAS DEPLOYED IN THE TARGET LESION. THE CATHETER HANDLE WAS NOT DELIBERATELY CRACKED TO AID STENT DEPLOYMENT. THE TIP WAS LEFT IN THE PATIENT. PROCEDURE WAS ABORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20408487 ↗
• MalfunctionMay 18, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST FOR THE TREATMENT OF A CALCIFIED LESION WITH 70% STENOSIS IN THE PROXIMAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE THUMBSCREW WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE AND IT WAS REMOVED ONCE THE STENT WAS POSITIONED AT THE LESION AND READY FOR DEPLOYMENT. IT WAS REPORTED THE SURGEON APPROACHED FROM THE PATIENT¿S BRACHIAL ARTERY, FIRST USED A 6MM BALLOON TO PRE-DILATE THE LESION, AND THEN USED A 7MM BALLOON TO DILATE, AND THEN ATTEMPTED TO USE AN 8MMX 40 STENT TO COMPLETE THE TREATMENT OF THE LESION, BUT IT WAS FOUND THAT AFTER THE STENT DELIVERY SYSTEM WAS SENT TO THE LESION AND WHEN READY TO DEPLOY, THE ROTATING THUMBWHEEL GOT STUCK AFTER ROLLING A FEW TIMES AND COULD NO LONGER BE OPERATED, SO THE WHOLE BODY WAS WITHDRAWN FROM THE PATIENT'S BODY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A LITTLE TIP OF THE STENT WAS EXPOSED UPON REMOVAL. THE STENT WAS REPLACED IN ORDER TO COMPLETE THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952915 ↗
• InjuryOct 20, 2022Premature Activation; Premature Activation

  A PATIENT WAS UNDERGOING BILATERAL ILIAC ANGIOPLASTY WITH STENT PLACEMENT WHEN THE EVERFLEX STENT SELF-DEPLOYED TOO EARLY. ADDITIONAL STENTS HAD TO BE PLACED TO PREVENT THE SELF-DEPLOYED STENT FROM TRAVELING IN THE INTRAVASCULAR SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 15643009 ↗

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