EverFlex™ EVD35-06-080-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00821684051368), received between Oct 13, 2017 and Mar 12, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE EVERFLEX ENTRUST STENT ALONG WITH A NON-MEDTRONIC 0.014 GUIDEWIRE, THERE WERE DEPLOYMENT ISSUES IN THE LEFT SUPERFICIAL FEMORAL ARTERY AT THE PROXIMAL LOCATION. THE TARGET LESION WAS IDENTIFIED AS PLAQUE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE STENT CROSSED THE LESION AND WAS DEPLOYED WITHOUT ISSUES AT THE DISTAL ASPECT OF THE DEVICE. DIFFICULTY WAS NOTED DURING THE DEPLOYMENT OF THE STENT, AS THE DEVICE WOULD NOT RELEASE THE STENT AT THE PROXIMAL SEGMENT. THE PHYSICIAN HAD TO MASSAGE THE PATIENT'S LEFT LEG TO FULLY RELEASE THE STENT. THE STENT WAS THEN POST-DILATED USING THE 6X150 IN.PACT ADMIRAL 018 DEVICE. PHOTOS AND VIDEOS OF THE DEVICE USED DURING THE PROCEDURE WERE AVAILABLE. THE PROCEDURE WAS COMPLETED USING THE STENT SYSTEM IN QUESTION, AND THE PHYSICIAN WAS SATISFIED WITH THE END RESULT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581641 ↗
• MalfunctionSep 17, 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 TO TREAT A LESION IN THE PROXIMAL POPLITEAL ARTERY. LESION STENOSIS WAS 80%. EMBOLIC WAS NOT PROTECTION USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IFU WAS FOLLOWED WITHOUT ISSUE. IT IS REPORTED THE STENT HOUSING WAS DETACHED FROM DEPLOYMENT ROLLER. THERE WAS NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. PROCEDURE WAS COMPLETED USING A NEW STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237964 ↗
• InjuryApr 28, 2022Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  PHYSICIAN USED AN EVERFLEX ENTRUST STENT WITH A SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A FIBROUS LESION IN THE PATIENT'S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. LESION EXHIBITED 85% STENOSIS. 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 AS PER IFU WITHOUT ISSUES IDENTIFIED. PRE-DILATION WAS PERFORMED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND REMOVED DURING ATTEMPTED INITIAL DEPLOYMENT OF STENT. DEPLOYMENT ISSUES ARE REPORTED LEADING TO PARTIAL DEPLOYMENT OF THE DEVICE. IT IS REPORTED THE DEPLOYMENT GEAR INSIDE THE PROXIMAL HANDLE DAMAGED THE GUIDEWIRE WHICH PROHIBITED DEPLOYMENT OF THE STENT. AN ATTEMPT WAS MADE TO REMOVE STENT, BUT WHEN ATTEMPTING TO REMOVE THE STENT BEGAN TO DEPLOY. THE PHYSICIAN ELECTED TO DEPLOY REMAINDER TO THE STENT WHERE IT WAS. PHYSICIAN HAD TO OPEN UP HANDLE AND USE KELLY'S TO DEPLOY STENT. THE STENT W

  Patient problems: Insufficient Information

  MAUDE report 14238995 ↗
• MalfunctionMar 25, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN EVERFLEX ENTRUST 6X80 STENT PACKAGE HAD A 6X60 STENT INSIDE. THE INTERNAL PRODUCT DID NOT MATCH THE EXTERNAL LABEL ON THE BOX. NO DAMAGE WAS NOTED TO PACKAGE. THE STENT FROM PACKAGE WAS DEPLOYED IN PATIENT. A SECOND STENT WAS USED TO COMPLETE PROCEDURE DUE TO ORIGINAL BEING TO SHORT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13900807 ↗
• MalfunctionJul 22, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT SYSTEM WITH A 5FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 140MM CALCIFIED LESION IN THE PATIENT¿S DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 4MM. SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. LESION EXHIBITED 85% STENOSIS. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT, BUT NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. NO DAMAGE WAS NOTED TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO ATTEMPTED DEPLOYMENT. THE LOCK-PIN WAS REMOVED ONCE TARGET LOCATION WAS REACHED AND STENT WAS READY TO DEPLOY. DEPLOYMENT ISSUES WERE NOTED. PARTIAL DEPLOYMENT IS REPORTED. THE PHYSICIAN LOST ACCESS WHEN REMOVING THE STENT AND SHEATH. ACCESS WAS REGAINED AND THE PHYSICIAN NOTICED THE HEPARIN WAS NOT WORKING AND HAD TO USE A UNIFIED THROMBOLYSIS CATHETER OVERNIGHT. THE NEXT DAY, AN EVERCROSS PTA BALL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10307831 ↗
• MalfunctionFeb 11, 2020Premature Activation; Positioning Problem; Premature Activation; Positioning Problem

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. NO DAMAGE NOTED TO PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS NOT CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. LESION PRE-DILATION WAS NOT PERFORMED. THE STENT WAS INSERTED INTO THE SHEATH BUT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT NOR WAS RESISTANCE ENCOUNTERED. THE LOCK-PIN WAS NOT REMOVED. ON REMOVAL OF THE DEVICE OF THE PATIENT IT WAS OBSERVED THAT THE STENT HAS PREMATURELY BEGUN TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH PTA ONLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9693137 ↗
• InjuryJan 31, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE A 6X80 EVERFLEX SELF-EXPANDING STENT WITH ENTRUST DELIVERY SYSTEM WITH A NON-MEDTRONIC 6FR SHEATH, A 0.14" SPIDER GUIDEWIRE AND A 6 MM SPIDER FX EMBOLIC PROTECTION FILTER FOR THE TREATMENT OF A MODERATELY CALCIFIED FIBROUS/PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) LESION IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). LESION WAS PRE-DILATED USING AN UNKNOWN 4 MM PRE-DILATION BALLOON. IFU WAS FOLLOWED AND DEVICE PREPPED WITHOUT ISSUE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND IT IS UNKNOWN IF EXCESSIVE FORCE WAS USED. THE LOCK-PIN WAS REMOVED ONCE IN POSITION IN THE LESION. IT WAS REPORTED 6X80 EVERFLEX ENTRUST STENT WAS STUCK TO THE SPIDER GUIDEWIRE, AND WAS UNABLE TO BE DEPLOYED. THIS STENT WAS REMOVED ALONG WITH THE GUIDEWIRE, LOSING THE LESION ACCESS. THE PHYSICIAN THEN RE-WIRED THE LESION WITH A NON-MEDTRONIC 0.14¿ GUIDEWIRE, AND INSERTED A 7X80 EVERFLEX ENTRUST STENT OVER THIS WIRE BUT WAS UNABLE TO DEPLOY THIS STENT. AN UNKNOWN 0.35" WIRE WAS THEN USED AND THE 6F SHEATH WAS SWAPPED OUT FOR A NEW UNKNOWN 6F SHEATH. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7230623 ↗
• MalfunctionOct 13, 2017Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN INTENDED TO USE AN EVERFLEX SELF-EXPANDING STENT WITH ENTRUST DELIVERY SYSTEM WITH FOR THE TREATMENT OF A SLIGHTLY CALCIFIED AND TORTUOUS PLAQUE LESION IN THE PROXIMAL LOCATION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY. LESION EXHIBITED 70% STENOSIS. DEVICE IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. A NON-MEDTRONIC 7 FR SHEATH WAS USED. THE PHYSICIAN REMOVED THE LOCK-PIN AFTER CROSSING THE LESION AND RIGHT BEFORE DEPLOYMENT. IT WAS REPORTED THAT THERE WAS DIFFICULTY ENCOUNTERED IN DEPLOYING THE STENT ¿ THE STENT WOULD NOT DEPLOY. THE PHYSICIAN MENTIONED THAT IT APPEARED THAT THE TANTALUM MARKER DOTS GOT CAUGHT UP ON THE STENT SHAFT AND WOULD NOT DEPLOY. THE DISTAL MARKER DOTS WOULD NOT DEPLOY/COME OUT OF SHAFT OF STENT. PHYSICIAN TRIED A SECOND EVERFLEX ENTRUST STENT, BUT THE SAME THING HAPPENED AGAIN. A DIFFERENT MODEL STENT (EVD35-06-100-120) WAS THEN USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6950300 ↗
• MalfunctionOct 13, 2017Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN INTENDED TO USE AN EVERFLEX SELF-EXPANDING STENT WITH ENTRUST DELIVERY SYSTEM WITH FOR THE TREATMENT OF A SLIGHTLY CALCIFIED AND TORTUOUS PLAQUE LESION IN THE PROXIMAL LOCATION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY. LESION EXHIBITED 70% STENOSIS. DEVICE IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. A NON-MEDTRONIC 7 FR SHEATH WAS USED. THE PHYSICIAN REMOVED THE LOCK-PIN AFTER CROSSING THE LESION AND RIGHT BEFORE DEPLOYMENT. IT WAS REPORTED THAT THERE WAS DIFFICULTY ENCOUNTERED IN DEPLOYING THE STENT ¿ THE STENT WOULD NOT DEPLOY. THE PHYSICIAN MENTIONED THAT IT APPEARED THAT THE TANTALUM MARKER DOTS GOT CAUGHT UP ON THE STENT SHAFT AND WOULD NOT DEPLOY. THE DISTAL MARKER DOTS WOULD NOT DEPLOY/COME OUT OF SHAFT OF STENT. PHYSICIAN TRIED A SECOND EVERFLEX ENTRUST STENT, BUT THE SAME THING HAPPENED AGAIN. A DIFFERENT MODEL STENT (EVD35-06-100-120) WAS THEN USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6950295 ↗

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