EverFlex™ EVD35-08-150-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00821684051559), received between Nov 21, 2019 and Aug 13, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232753 ↗
• MalfunctionAug 13, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232725 ↗
• MalfunctionNov 27, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF PLAQUE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY USING THE EVERFLEX ENTRUST 8X150X120, THERE WERE DEPLOYMENT ISSUES SPECIFICALLY DESCRIBED AS AN INABILITY TO DEPLOY. UPON REMOVAL, STENT STRUTS WERE EXPOSED AND VISIBLE. EMBOLIC PROTECTION WAS USED WITH A SPIDER WIRE DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITHOUT INTERVENTION, AND THE PROCEDURE WAS COMPLETED USING A NEW EVERFLEX 8MM X 150MM DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE STENT GOT CAUGHT ON THE SPIDER WIRE, SO THEY PULLED EVERYTHING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665768 ↗
• MalfunctionJun 20, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF PLAQUE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, MID LOCATION, WITH A LESION LENGTH OF 150MM AND ARTERY DIAMETER OF 8MM, THE EVERFLEX ENTRUST STENT EXPERIENCED PARTIAL DEPLOYMENT AT THE TARGET SITE WITHIN THE PATIENT VASCULATURE. THE VESSEL WAS BOTH PRE-DILATED AND POST-DILATED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND THE THUMBSCREW/LOCK-PIN WAS CHECKED AND REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE STENT REMAINS IN THE PATIENT, AND NO ATTEMPTS WERE MADE TO REMOVE IT. THE DELIVERY SYSTEM WAS SAFELY REMOVED. THE PROCEDURE WAS COMPLETED BY CRACKING THE HANDLE OPEN AND PULLING THE SYSTEM. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE OUTCOMES, ILLNESSES, INFECTIONS, IRREGULARITIES, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297110 ↗
• MalfunctionNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EVERFLEX ENTRUST STENT TO TREAT A FIBROUS LESION IN THE LEFT PROXIMAL MID DISTAL SUPERFICIAL FEMORAL ARTERY. LESION LENGTH WAS 150MM. ARTERY/VEIN DIAMETER WAS 6.5-7.5MM. A 5FR COOK 55CM WAS USED. A ASAHI BLACK SION .014 WAS USED. EMBOLIC PROTECTION WAS NOT USED. STENT NOSECONE TIP DETACHED IN VIVO WITHIN SHEATH. DID NOT FULLY DETACH, DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITH THE STENT CATHETER. A EVERFLEX ENTRUST 08-150-120 WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20743240 ↗
• MalfunctionNov 15, 2024Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  A PHYSICIAN WAS IMPLANTING AN EVERFLEX ENTRUST FOR TREATMENT OF A 150 MM PLAQUE LESION WITH 100% STENOSIS IN THE PROXIMAL/MID REGION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6 MM IN DIAMETER WITH MINIMAL TORTUOSITY AND NO CALCIFICATION. A 7 FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE WERE USED. A 3 X 120 MM EVERCROSS WAS USED FOR PRE-DILATION. THE IFU WAS FOLLOWED. IT IS UNKNOWN IF THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE MET DURING ADVANCEMENT OF THE DEVICE. THE IFU WAS FOLLOWED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE, AND IT WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. IT WAS REPORTED THE DEVICE PARTIALLY DEPLOYED AT THE TARGET SITE. NO ATTEMPTS WERE MADE TO REMOVE THE STENT. THE DEPLOYED STENT WAS ELONGATED, IT WAS 200 MM IN THE VESSEL. THE DELIVERY SYSTEM WAS SAFELY REMOVED. NO OTHER ACTIONS WERE TAKEN AS A RESULT OF THE PRE-DEPLOYMENT. NO VESSEL DAMAGE NOTED. THE VESSEL WAS POST DILATED WITH A 5 X 200 MM EVERCROSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692737 ↗
• MalfunctionFeb 20, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF EXPANDING STENT WITH A 5FR SHEATH AND A 0.035 GUIDEWIRE DURING TREATMENT OF AN 180MM FIBROUS LESION IN THE PATIENT¿S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND LITTLE VESSEL CALCIFICATION WERE REPORTED. ARTERY DIAMETER REPORTED AS 8MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, (I.E. SHELF CARTON, HOOP/TRAY). NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE VESSEL WAS NOT PRE-DILATED. THE STENT WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK PIN WAS REMOVED AFTER INSERTION INTO THE BODY. IT WAS REPORTED THE STENT WAS UNABLE TO FULLY DEPLOY. STENT CATHETER HANDLE HAD TO BE OPENED AND MANUAL DEPLOYMENT WAS COMPLETED TO DELIVER THE STENT. NO DEFORMATION NOTED TO THE DEPLOYED STENT. THE DELIVERY SYSTEM WAS SAFELY REMOVED. PROCEDURE WAS COMPLETED AND PATIENT DID FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743390 ↗
• InjuryJan 25, 2024Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH A 6FR SHEATH AND DURING TREATMENT OF AN 80MM CALCIFIED LESION IN THE PATIENTS LEFT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). LITTLE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. 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 DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 5MM EVERCROSS PTA BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED UPON DEPLOYMENT THE PHYSICIAN STATED THE THUMBWHEEL STOPPED WORKING. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. PHYSICIAN HAD FORGOTTEN HOW TO MANUALLY DEPLOY THE ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580699 ↗
• MalfunctionFeb 11, 2021Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT DURING TREATMENT OF A LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA), SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE THUMBSCREW/LOCK PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED THAT DEPLOYMENT ISSUES WERE NOTED. THE LOCK-PIN WAS REMOVED RIGHT BEFORE DEPLOYMENT ATTEMPT. THE STENT WAS SECURED IN THE DESIRED LOCATION AND STENT FLOWERED. THE PHYSICIAN THEN HAD DIFFICULTY DELIVERY THE REST OF THE STENT. IT IS REPORTED THE DEPLOYMENT SHEATH SEEMED TO PULL BACK THE STENT ALONG WITH IT INSTEAD OF ALLOWING IT TO RELEASE. THIS ELONGATED THE STENT. THE STENT WAS EVENTUALLY RELEASED FROM THE DEPLOYMENT SYSTEM BUT WAS STRETCHED OUT. THE PROCEDURE WAS COMPLETED BY BALLOON ANGIOPLASTY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312979 ↗
• InjuryNov 21, 2019Material Deformation; Material Deformation

  PHYSICIAN USED AN EVERFLEX ENTRUST SELF-EXPANDING STENT SYSTEM WITH A NON-MEDTRONIC 5F SHEATH AND 0.014 GUIDEWIRE DURING TREATMENT OF A 150MM, CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 8MM. SEVERE VESSEL CALCIFICATION AND MODERATE TORTUOSITY ARE REPORTED. EMBOLIC PROTECTION WAS NOT USED. IFU WAS FOLLOWED. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING DEVICE FROM PACKAGING. DEVICE PREPPED WITHOUT ISSUE. ACCESS AS VIA THE RIGHT POPLITEAL ARTERY WITH THE 5F SHEATH. ANGIOGRAM OF THE RIGHT SFA AND COMMON FEMORAL ARTERY WERE TAKEN. ANGIOGRAM SHOWED CTO OF RIGHT COMMON FEMORAL AND SFA. THE EVERFLEX ENTRUST STENT WAS DEPLOYED THROUGH THE RIGHT COMMON FEMORAL AND SFA. AFTER STENT DEPLOYMENT A CRUMBLE MID-SECTION OF STENT WAS NOTICED. A NON-MEDTRONIC BALLOON WAS USED IN THE RIGHT COMMON FEMORAL AND SFA TO POST DILATE. THE STENT STILL APPEARED DEFORMED, SO A NON-MEDTRONIC STENT WAS DEPLOYED INSIDE THE DEFORMED ENTRUST EVERFLEX STENT. NO ADVERSE EVENT REPORTED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9353221 ↗

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