EverFlex™ EVD35-06-120-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00821684051382), received between May 23, 2017 and Dec 24, 2025 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY PROCEDURE INVOLVING THE EVERFLEX ENTRUST 6X120X120, DIFFICULTY WAS NOTED DURING DEPLOYMENT. THE STENT WAS PARTIALLY DEPLOYED BEFORE MANUAL INTERVENTION. THE STENT HANDLE HAD TO BE OPENED AND THE DEPLOYMENT WIRE WAS EXPOSED AND PULLED TO COMPLETE STENT DEPLOYMENT. THE PROCEDURE INVOLVED THE SUPERFICIAL FEMORAL ARTERY, WITH A 6FR SHEATH AND SPIDER FX GUIDEWIRE AND EMBOLIC PROTECTION DEVICE USED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE STENT WAS DEPLOYED SUCCESSFULLY WITHOUT INJURY OR INTERVENTION, AND THE DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887617 ↗
• MalfunctionJun 18, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING PLAQUE IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY, THE EVERFLEX ENTRUST 6X120X120 STENT WAS ADVANCED OVER A 300CM 0.014-INCH NITREX GUIDEWIRE WITH SEVERE RESISTANCE ENCOUNTERED. A 45CM 6FR NON-MEDTRONIC SHEATH WAS USED. FLUOROSCOPY WAS USED TO VISUALIZE THE NON-MEDTRONIC SHEATH AND STENT POSITION, REVEALING THAT THE NON-MEDTRONIC SHEATH HAD REPOSITIONED ITSELF UP THE AORTA AND THE STENT SHAFT WAS TWISTED WITHIN THE NON-MEDTRONIC SHEATH. UPON REMOVAL OF THE STENT CATHETER, THE STENT WAS FOUND PARTIALLY DEPLOYED OUTSIDE THE DELIVERY SYSTEM AT THE SHEATH HUB AND WAS REMOVED IN ITS ENTIRETY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE TREATED LESION WAS CHARACTERIZED BY SEVERE CALCIFICATION, 75% STENOSIS, A LENGTH OF 100 MM, AND A DIAMETER OF 6 MM. THE VESSEL WAS PRE-DILATED WITH A 4X60 NANOCROSS BALLOON. THE VESSEL WAS POST-DILATED WITH A 4X150 EVERCROSS BALLOON. A REPLACEMENT EVERFLEX ENTRUST STENT WAS SUCCESSFULLY IMPLANTED USING A 0.035-INCH WIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22281984 ↗
• MalfunctionOct 31, 2024Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST STENT ALONG WITH 6FR NON-MEDTRONIC SHEATH AND .014 NITREX GUIDEWIRE DURING TREATMENT OF CALCIFIED LESION IN PATIENTS LEFT PROXIMAL/MID/DISTAL COMMON ILIAC ARTERY. SEVERE CALCIFICATIONS WERE REPORTED. ARTERY DIAMETER REPORTED AS 6-8MM AND LESION DIAMETER REPORTED AS 130 MM. LESION EXHIBITED 100% STENOSIS. 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 DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. EMBOLIC PROTECTION WAS NOT USED. MEDTRONIC NANOCROSS WAS USED FOR PRE-DILATION AND MEDTRONIC EVERCROSS WAS USED FOR POST-DILATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND THE THUMBSCREW/LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. IT WAS REPORTED THAT DEPLOYMENT ISSUES WERE ENCOUNTERED, THE INITIAL 20 MM WAS SUCCESSFUL THEN THUMB WHEEL MADE A POP SOUND AND WOULD NOT SPIN. THE PHYSICIAN ATTEMPTED TO RETRACT THE STENT WHICH ELONGATED MID-SECTION OF THE STENT. THE "DEPLOYMENT WORKAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578664 ↗
• InjuryFeb 8, 2024Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EVERFLEX ENTRUST TO TREAT A PLAQUE LESION IN THE RIGHT MID ILIAC ARTERY - COMMON. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS LITTLE. A 5 FR TERUMO DESTINATION SHEATH WAS USED. A .035 GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING DELIVERY TO LESION. EXCESSIVE FORCE WAS NOT USED. DEVICE WAS UNABLE TO DEPLOY. THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. LOCK-PIN WAS REMOVED BEFORE STARTING THE PROCESS TO DEPLOY THE STENT. THE HUB OF THE STENT WAS FORCED OPEN IN ORDER TO EXPOSE THE WIRE. THE STENT WAS THEN MANUALLY DEPLOYED. THE STENT WAS DEPLOYED IN AN AREA AWAY FROM THE TARGET LESION. THE STENT WAS MOVED AND PINNED ON THE SIDE OF THE ARTERY WALL USING ANOTHER STENT THE OTHER STENT THAT WAS USED WAS THE SAME SIZE, BUT DIFFERENT LOT NUMBER. THE CASE WAS COMPLETED WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668697 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A EVERFLEX ENTRUST AND A NON-MEDTRONIC STENT WAS USED TO TREAT THE SUPERFICIAL FEMORAL PROXIMAL, POPLITEAL 1 SEGMENT. APPROXIMATELY 2 MONTHS POST PROCEDURE PATIENT SUFFERED OCCLUSION TO RIGHT SUPERFICIAL FEMORAL AND POPLITEAL ARTERY STENTS. PATIENT IS RECOVERING. PATIENT WAS NOT TREATED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18355429 ↗
• MalfunctionDec 17, 2021Fracture; Fracture

  PHYSICIAN WAS ATTEMPTING TO USE THE EVERFLEX ENTRUST STENT DURING PROCEDURE TO TREAT MODERATELY CALCIFIED PLAQUE IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY(SFA). THE VESSEL HAD NO TORTUOSITY AND EXHIBITED CTO(CHRONIC TOTAL OCCLUSION-100%).THE ARTERY DIAMETER WAS 6MM AND LESION LENGTH WAS 120MM. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THERE WAS NO ALLEGED PRODUCT ISSUE. THE LESION WAS PRE-DILATED WITH A 6 PRE-DILATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE STENT WAS DEPLOYED. PATIENT IS FINE BUT PHYSICIAN NOTICED A STENT FRACTURE ON POST ANGIOGRAM. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024342 ↗
• MalfunctionDec 7, 2021Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH A 6FR X 55 SHEATH DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED PLAQUE LESION IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUE IDENTIFIED. IT WAS REPORTED THAT DEPLOYMENT ISSUE OCCURRED WITH PARTIAL DEPLOYMENT REPORTED. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISM 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. THE LESION WAS PRE DILATED WITH A 5X250 PRE DILATATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. MID WAY THROUGH DEPLOYED STENT WHEEL GOT TOUGH TO TURN, AND USED ADDITIONAL FORCE, IT SOUNDED LIKE THE WHEEL SNAPPED. THE STRING DETACHED INSIDE HANDLE, NOT ALLOWING STENT TO DEPLOY AND WHEEL MOVED FREELY. PHYSICIAN CRACKED OPENS THE THUMB WHEEL AND DEPLOYED STENT REST OF THE WAY WITH GOLD LAYER OF SHEATH. PATIENT EXPERIENCED CLAUDICATION

  Patient problems: Pain

  MAUDE report 12953195 ↗
• MalfunctionSep 30, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE THE EVERFLEX ENTRUST SELF EXPANDING STENT TO TREAT SEVERELY CALCIFIED LESION IN THE MID LOCATION OF THE LEFT SUPERFICIAL FEMORAL ARTERY(SFA). VESSEL EXHIBITED CTO(CHRONIC TOTAL OCCLUSION-100%). THERE WAS LITTLE VESSEL TORTUOSITY. THE ARTERY DIAMETER WAS 6MM AND LESION LENGTH WAS 120MM. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT. THE THUMBSCREW WAS NOT CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND THE LOCK-PIN WAS NOT REMOVED, THE VESSEL WAS PRE-DILATED WITH A 6X150 PRE-DILATION DEVICE. IT WAS REPORTED THAT THERE WAS PARTIAL DEPLOYMENT. THE THUMBWHEEL BROKE DUE TO EXCESSIVE FORCE WITH SAFETY STILL IN PLACE, STRING FOR DEPLOYMENT BROKE. THE PROCEDURE WAS COMPLETED BY TAKING THE ENTRUST HANDLE APART AND MANUALLY PULLING BACK THE DEPLOYMENT SHEATH. THE STENT WAS DEPLOYED IN THE TARGET LESION. NO INTERVENTION REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12553904 ↗
• InjuryJul 27, 2021Fracture; Activation, Positioning or Separation Problem; Positioning Problem; Fracture; Activation, Positioning or Separation Problem; Positioning Problem

  PHYSICIAN WAS ATTEMPTING TO USE EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 8FR SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED PLAQUE LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY WITH 90% STENOSIS. THE VESSEL WAS SEVERELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6-8MM AND 250MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. ANGULATED AORTA AND TOUGH BIFURCATION WERE THE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DEPLOYMENT ISSUE WITH PARTIAL DEPLOYMENT OCCURRED. 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 ONCE THE STENT WAS IN PLACE. THE LESION WAS PRE DILATED WITH A 5MM DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT HANDLE WAS BROKEN AND THE PHYSICIAN ATTEMPTED TO DEPLOY MANUALLY

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12232033 ↗
• MalfunctionDec 23, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE A EVERFLEX ENTRUST SELF-EXPANDING STENT AND A SPIDER FX DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION AND TORTUOSITY AND CALCIFICATION ARE REPORTED. PRIOR TO USE OF STENT ATHERECTOMY HAD BEEN PERFORMED. IFU WAS FOLLOWED. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FORM THE PACKAGING. THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE STENT WAS INITIALLY DEPLOYED HALFWAY, THEN THE PHYSICIAN OBSERVED THAT THE DEPLOYMENT WHEEL WAS STUCK BECAUSE THERE WAS A PORTION OF THE RED LOCK, THAT WAS NOT COMPLETELY REMOVED PRIOR TO STENT DEPLOYMENT. THE PHYSICIAN BROKE THE STENT HANDLE IN HALF, REMOVED THE RESIDUAL RED LOCK THAT WAS STUCK IN THE DEPLOYMENT WHEEL. THE PHYSICIAN THEN PIN AND PULLED THE DEVICE TO COMPLETELY DEPLOY THE STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11065048 ↗
• MalfunctionAug 9, 2019Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN USED AN EVERFLEX ENTRUST WITH A 7FR SHEATH AND 0.014 7 MM SPIDER FX DURING TREATMENT OF A 100 MM CTO (CHRONIC TOTAL OCCLUSION -100%) IN THE PATIENT¿S PROXIMAL, MID, AND DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. LESION DESCRIBED AS CALCIFIED. MODERATE TORTUOSITY AND SEVERE CALCIFICATION REPORTED. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. ATHERECTOMY PERFORMED FOLLOWED BY PRE-DILATION WITH A 5 MM (STERLING) PTA BALLOON. THE EVERFLEX ENTRUST WAS ADVANCED TO THE TARGET AREA WITHOUT ANY ISSUE, NO RESISTANCE ENCOUNTERED. DEPLOYMENT WAS ATTEMPTED AND IT IS REPORTED THAT APPROXIMATELY HALF-WAY THROUGH DEPLOYMENT, THE STENT THUMBWHEEL STOPPED WORKING AND THE STENT STOPPED DEPLOYING. IT IS REPORTED THE THUMBWHEEL FELL APART. THE PHYSICIAN HAD TO PIN THE WIRE AND PULL THE STENT SYSTEM BACK. THIS ALLOWED THE STENT TO FULLY DEPLOY BUT WAS SEVERELY ELONGATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8878198 ↗
• MalfunctionJun 26, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN WAS USING ONE EVERFLEX ENTRUST DEVICE TO TREAT A SLIGHTLY CALCIFIED AND SLIGHTLY TORTUOUS MID SFA LESION (5 X 100 MM) EXHIBITING 80% STENOSIS. A NON-MEDTRONIC SHEATH ( 6 COOK RAABE) AND GUIDEWIRE ( 035 ROSEN) WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED DURING THE PROCEDURE. THE LESION WAS PREDILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT AFTER STENT DEPLOYMENT, THE CATHETER HANDLE DETACHED FROM THE CATHETER OUTSIDE THE SHEATH. THE PHYSICIAN WALKED OUT THE DEVICE BY HAND, THE CATHETER WAS ABLE TO BE REMOVED OVER THE WIRE WITH WHAT WAS OUT OF THE SHEATH. DIFFICULTY WAS EXPERIENCED WHILE REMOVING THE DEVICE. THE CATHETER DID NOT CATCH ON THE STENT DURING WITHDRAWAL. NO INTERVENTION WAS NEEDED AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7637547 ↗
• MalfunctionMay 23, 2017Difficult or Delayed Positioning; Retraction Problem; Difficult or Delayed Positioning; Retraction Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE ONE EXERFLEX STENT TO TREAT A LESION LOCATED IN THE SFA. THE DEVICE WAS REMOVED FROM ITS PACKAGING, PREPPED PER THE IFU AND INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT WHEN THE PHYSICIAN SUCCESSFULLY POSITIONED THE DEVICE, THE RED BARRIER WAS REMOVED BUT WHEN THEY BEGAN TURNING THE DIAL TO DEPLOY IT CLICKED 3 TIMES, HOWEVER THE STENT WOULD NOT DEPLOY. WHEN THEY TRIED TO BRING IT BACK OVER THE WIRE, THE TWO WERE STUCK TOGETHER. IN THE END, EVERYTHING WAS REMOVED. THE PHYSICIAN THEN REGAINED ACCESS AND FINISHED THE PROCEDURE USING A DCB. LATER THE STENT WOULD NOT DEPLOY WHEN TESTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6586638 ↗

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