EverFlex™ EVD35-07-060-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821684051672), received between Dec 5, 2016 and Aug 19, 2025 — classified as 2 injuries, 3 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 16, 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.

• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN.PACT ADMIRAL BALLOON AND AN EVERFLEX ENTRUST STENT WERE USED TO TREAT THE RIGHT SUPERFICIAL FEMORAL DISTAL. APPROXIMATELY 28 MONTHS POST PROCEDURE PATIENT SUFFERED OCCLUSION OF THE MID PORTION OF THE STENT. PATIENT REPORTED NON-HEALING ULCER IN, WHICH WAS PRESENT APPROXIMATELY FOR TWO MONTHS. REFERRED FOR PERIPHERAL ANGIOGRAPHY. THE MID PORTION OF THE STENT WAS OCCLUDED WITH RECONSTITUTION AT THE DISTAL END OF THE STENT. REVISION TO THIS AREA INCLUDED SHOCKWAVE, BALLOON DILATION, AND USE OF A DRUG ELUTING BALLOON. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion; Ulcer

  MAUDE report 22843362 ↗
• InjuryFeb 24, 2023Material Deformation; Material Deformation

  AN EVERFLEX ENTRUST STENT WAS USED FOR TREATMENT OF A LESION IN THE DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. AN N.PACT ADMIRAL BALLOON WAS ALSO USED DURING THE PROCEDURE. IT WAS REPORTED THAT THE EVERFLEX STENT WAS DEPLOYED AND WAS SHOWN TO BE POSSIBLY TWISTED WITHIN THE VESSEL. A NON-MEDTRONIC SELF EXPANDING STENT WAS THEN DEPLOYED IN THE ABNORMAL AREA OF THE PRIOR MEDTRONIC STENT. A NON-MEDTRONIC BALLOON WAS THEN USED TO POST DILATE. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16436905 ↗
• MalfunctionDec 22, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  A PHYSICIAN WAS IMPLANTING AN EVERFLEX SELF EXPANDING STENT WITH THE ENTRUST DELIVERY SYSTEM FOR THE TREATMENT OF A 120MM CALCIFIED LESION WITH 95% STENOSIS IN THE MID LEFT REGION OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ARTERY DIAMETER WAS 6MM AND THERE WAS MODERATE TORTUOSITY AND SEVERE CALCIFICATION. PATIENT HAS PREVIOUS ILIAC DISEASE. THE DEVICE WAS PREPPED AS PER THE IFU WAS NO ISSUES IDENTIFIED. A 0.014" NON MDT GUIDEWIRE AND A 6FR X 55CM NON MDT SHEATH WERE USED.  THE LESION WAS PREDILATED WITH 5.0 SHOCKWAVE, 6.0 X 80 CHOCOLATE, AND 6.0 X 120 INPACT ADMIRAL. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE PATIENT PRESENTED WITH HEAVILY CALCIFIED LEFT SFA. PHYSICIAN ELECTED TO PRE TREAT THE VESSEL WITH A 5.0 X 60 SHOCKWAVE IVL, PERFORMING MULTIPLE INFLATIONS AND PULSES. THE BALLOON CROSSED THE LESION WITHOUT DIFFICULTY. PHYSICIAN FOLLOWED SHOCKWAVE CATHETER WITH 6.0 X 80 CHOCOLATE BALLOON. BALLOON CROSSED WITHOUT ISSUE AND WAS INFLATED FOR 2 MINUTES. FOLLOWING PHYSICIAN USED A 6 X 120 INPACT ADMIRAL BALLOON. THE PHYSICIAN ELECTED TO SPOT STENT THE LESION AND PLACED A 7 X 60 EVERFLEX WITH ENTRUST. NO ISSUES WITH PREP AND CROSSED THE LESION WITHOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16032493 ↗
• MalfunctionJun 6, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED AN EVERFLEX ENTRUST WITH A 6F NON-MDT SHEATH AND A NON-MDT 260 GUIDEWIRE FOR TREATMENT OF A 60MM MODERATELY CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY(SFA) OF DIAMETER 6MM. THE LESION WAS REPORTED TO EXHIBIT 90% STENOSIS SEVERE TORTUOSITY. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO DEPLOYMENT. THE LESION WAS PRE-DILATED USING A 6X40 EVERCROSS PTA BALLOON. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THE PHYSICIAN ATTEMPTED TO DRIVE THE STENT THROUGH THE SHEATH IT WOULDN¿T GO PAST AORTIC BIFURCATION WHERE KISSING STENTS WERE LOCATED. UPON REMOVING THE DEVICE FROM THE PATIENT, A FEW MM OF THE STENT WAS SEEN TO HAVE PARTIALLY DEPLOYED ON TIP OF CATHETER OUTSIDE OF THE SHEATH. A NEW EVERFLEX ENTRUST WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7573165 ↗
• MalfunctionDec 5, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PHYSICIAN USED THE EVERFLEX ENTRUST TO TREAT THE SUPERFICIAL FEMORAL ARTERY AS PER IFU. THE PHYSICIAN ADVANCED THE EVERFLEX ENTRUST THROUGH A PREVIOUSLY DEPLOYED STENT TO REACH THE LESION - THE STENT WAS DEPLOYED WITHOUT ISSUE. IT WAS REPORTED THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING THE EVERFLEX DELIVERY SYSTEM FOLLOWING STENT DEPLOYMENT. THIS RESULTED IN THE CATHETER SNAPPING INTO TWO PIECES. THE CATHETER DID NOT INTERACT WITH THE PREVIOUSLY DEPLOYED STENT AND WAS REMOVED FROM THE PATIENT ON THE WIRE. THE PIECES OF BROKEN CATHETER WERE REMOVED FROM THE PATIENT'S LEG. NO INJURY TO THE PATIENT REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6144418 ↗

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