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

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00821684051719), received between Apr 20, 2018 and Sep 6, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT DURING TREATMENT OF THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. DIFFICULTY DURING DEPLOYMENT WAS REPORTED. THE STENT WHEEL WOULD NOT DEPLOY STENT. GUIDEWIRE ALSO GOT STUCK. THE STENT HAD TO BE DEPLOYED MANUALLY. THE STENT WAS DEPLOYED SUCCESSFULLY WITHOUT INJURY/INTERVENTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157294 ↗
• MalfunctionJun 14, 2021Premature Activation; Malposition of Device; Activation, Positioning or Separation Problem; Premature Activation; Malposition of Device; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE EVERFLEX ENTRUST SELF-EXPANDING STENT DURING PROCEDURE TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THAT WHEN PHYSICIAN STARTED DEPLOYING THE STENT, ONCE IT REACHED THE DESIRED ZONE AND WAS ABOUT A QUARTER OF THE WAY THROUGH, PHYSICIAN NOTICED THAT IT WAS NOT VISIBLY FLOWERING, DEPLOYING WITHIN THE VESSEL. TOOK A FEW MORE SHOTS UNDER FLUOROSCOPY WHILE SLOWLY DEPLOYING AND STILL COULD NOT SEE THE STENT. IT WAS DECIDED TO ABORT AND PULL BACK THE DELIVERY SYSTEM AS THERE WAS CLEARLY AN ISSUE AND THERE WAS NO VISIBLE STENT. THE DELIVERY CATHETER WAS REMOVED FROM PATIENT AND THE CASE WAS CONTINUED. UPON FURTHER IMAGING SOMETHING ABNORMAL WAS NOTICED IN A PICTURE UP NEAR THE ILIOFEMORAL AREA. THE STENT SOMEHOW ENDED UP IN THE RIGHT EXTERNAL ILIAC ARTERY (REIA), IT WAS NEVER VISUALIZED UPON WHAT SHOULD HAVE BEEN DEPLOYMENT WITHIN THE R SFA, AND NOTHING WAS VISUALIZED AS IT WAS BACKED OUT OF THE PATIENT. PHYSICIAN BALLOONED THE STENT OPEN WHERE IT WAS, AS IT WAS DECIDED THAT ATTEMPTING TO RETRIEVE IT THROUGH OUR CONTRALATERAL ACCESS WOULD HAVE POTENTIALLY CAUSED MORE ISSUES THAN LEAVING A STENT OF THE WRONG DIAMETER IN THE REIA. STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992014 ↗
• MalfunctionNov 5, 2020Premature Activation; Activation, Positioning or Separation Problem; Premature Activation; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC WIRE DURING TREATMENT OF A 130MM FIBROUS LESION IN THE PATIENT¿S PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. ARTERY DIAMETER REPORTED AS 7MM. LESION EXHIBITED 90% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING A NON-MEDTRONIC DEVICE AND A PACIFIC XTREME PTA BALLOON. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. DEPLOYMENT ISSUES ARE REPORTED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. PARTIAL DEPLOYMENT IS REPORTED. THE PHYSICIAN WAS ADVISED TO CRACK THE HANDLE OF THE DELIVERY SYSTEM AND DEPLOY THE REMAINDER OF THE STENT BY GRABBING THE STRING WITH A HAEMOSTAT. THIS WAS SUCCESSFUL AND THE STENT DEPLOYED SUCCESSFULLY. NO PAINT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10790868 ↗
• MalfunctionMay 20, 2020Positioning Problem; Positioning Problem

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 200MM CALCIFIED LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION IS 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 DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE IS REPORTED DURING ADVANCEMENT OF THE DEVICE. 50/50 SALINE/CONTRAST MIX WAS USED FOR BALLOON INFLATION. IT IS REPORTED THAT A BALLOON BURST OCCURRED DURING INFLATION OF THE BALLOON. BALLOON DID NOT FRAGMENT. NO VESSEL DAMAGE WAS NOTED. THE BALLOON WAS SAFELY REMOVED FROM THE PATIENT WITHOUT INTERVENTION. THE PHYSICIAN THEN DECIDED TO TREAT WITH AN EVERFLEX ENTRUST SELF-EXPANDING STENT SYSTEM USING THE SAME SHEATH AND WIRE. 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. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10074627 ↗
• InjuryMay 7, 2020Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SE STENT ALONG WITH NON MEDTRONIC 5FR SHEATH AND 0.018 GUIDE WIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT PROXIMAL POPLITEAL. THE VESSEL IS SEVERELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 150MM RESPECTIVELY. THERE WAS NO DAMAGE TO DEVICE PACKAGE. THERE WERE NO ISSUES WHILE REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PREDILATED USING A NON MEDTRONIC PTA BALLOON. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO FORCE USED WHILE ADVANCING THE DEVICE. IT WAS REPORTED THAT THE RIGHT POPLITEAL ARTERY SHOWED A IN-STENT RESTENOSIS. THE VESSEL WAS PREPPED WITH A 4 X 60 NON MEDTRONIC BALLOON. WHILE DEPLOYING ENTRANCE EVERFLEX STENT 7X150X150 THE PROXIMAL END OF THE STENT STARTED TO CRUMBLE FOR A SHORT SEGMENT AND THEN THE REMAINING OF THE STENT DEPLOY NORMALLY. A 6 X 80 NON MEDTRONIC BALLOON 035 WAS USED TO POST DILATE, FOLLOWED BY A 6 X 60 SABER .018 NON MEDTRONIC BALLOON. A 5X150 NON MEDTRONIC COVER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 10032999 ↗
• MalfunctionJan 15, 2019Stretched; Activation, Positioning or Separation Problem; Material Deformation; Stretched; Activation, Positioning or Separation Problem; Material Deformation

  THE PHYSICIAN WAS ATTEMPTED TO USE AN EVERFLEX ENTRUST IN THE PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) TO TREAT A 120MM MODERATELY CALCIFIED FIBROUS SOFT TISSUE CHRONIC TOTAL OCCLUSION (CTO). NO PATIENT ANATOMY ABNORMALITIES WERE REPORTED. LITTLE TORTUOSITY WAS REPORTED IN THE 7MM ARTERY. A 6FR NON MEDTRONIC SHEATH AND A NON MEDTRONIC GUIDEWIRE WAS USED IN THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. PRE-DILATION WAS COMPLETED WITH A 4MM AND 5MM DEVICE. THERE WAS NO DAMAGE OBSERVED TO THE DEVICE DURING REMOVAL FROM PACKAGING. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED AND THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISM OR HANDLE PRIOR TO USE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT DEPLOYMENT ISSUES WERE ENCOUNTERED, THE STENT PARTIALLY DEPLOYED IN THE PATIENT AND STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING / DEPLOYMENT. THE THUMB WHEEL STOPPED WORKING AND THE STENT COULD NOT BE COMPLETELY DEPLOYED BY UNWINDING THE THUMB WHEEL FURTHER. THE STENT WAS MANUALLY DEPLOYED AND 10-20MM STENT ELONGATION WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING POST DILATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8247846 ↗
• MalfunctionApr 20, 2018Difficult or Delayed Positioning; Retraction Problem; Difficult or Delayed Positioning; Retraction Problem

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE A 6 X 150 EVERFLEX ENTRUST DEVICE TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LEFT DISTAL SFA 120MM LESION EXHIBITING 80% STENOSIS. ACCESS WAS THROUGH THE LEFT BRACHIAL ARTERY. THE VESSEL DIAMETER WAS REPORTED TO BE 6MM IN DIAMETER. A NON-MEDTRONIC 6F SHEATH AND A NON-MDT 018 GUIDEWIRE WERE USED. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED DURING PREP. THE LESION WAS PREDILATED WITH A 4MM DEVICE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED AAA ENDOGRAFT STENT WHICH HAD A PRONOUNCED ANGLE IN THE AORTA AT THE LEVEL OF THE RENAL ARTERIES. IT WAS REPORTED THAT THE DEVICE WOULD NOT DEPLOY AND THE DEVICE WAS WITHDRAWN. THE LESION AREA WAS REDILATED WITH A 6MM BALLOON. THE PHYSICIAN THEN OPENED A NEW 7 X 150 EVERLFEX ENTRUST DEVICE. A NON-MEDTRONIC 6F SHEATH AND A NON-MDT 035 GUIDEWIRE WERE USED. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED DURING PREP. ACCESS WAS THROUGH THE LEDT BRACHIAL ARTERY. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED AAA ENDOGRAFT ST

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7446174 ↗

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