EverFlex™ EVD35-07-060-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821684051436), received between Jun 30, 2017 and May 19, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 3, 2017Terminated

   Stent length on the label may not match the length of the stent itself.

   Z-0188-2018 · Root cause: Employee error · Recall details · FDA record ↗

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.

• MalfunctionMay 19, 2025Defective Device; Difficult to Advance; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE EVERFLEX ENTRUST, THE PHYSICIAN MENTIONED THAT THE DEVICE FELT UNUSUAL GOING INTO THE BODY AND HAD CONCERNS OVER DEPLOYING IT. MODERATE RESISTANCE WAS MET DURING ADVANCEMENT. THE DEVICE WAS INTENDED TO A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION WAS CALCIFIED WITH MINIMAL TORTUOSITY, MEASURING 60MM IN LENGTH AND 7MM IN DIAMETER. THE VESSEL WAS PRE-DILATED AND POST-DILATED, AND THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW EVERFLEX. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042239 ↗
• InjuryMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO IMPLANT AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 45CM 6FR NON-MEDTRONIC SHEATH AND AN 014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 50MM CALCIFIED PLAQUE LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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 IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH A TURBOHAWK PLUS ATHERECTOMY DEVICE. THE VESSEL WAS POST-DILATED WITH A 6X60 NANOCROSS BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THE TIP OF CATHETER WITH MARKER BAND DETACHED WITHIN THE SHEATH IN VIVO. THE STENT WAS FULLY DEPLOYED, NO DEFORMATION NOTED TO THE DEPLOYED STENT. PHYSICIAN USED A CORONARY BALLOON TO DRAG OUT THE DETACHED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369176 ↗
• MalfunctionJul 6, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EVERFLEX ENTRUST TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED PER THE IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THERE WAS DEPLOYMENT ISSUES. PARTIAL DEPLOYMENT  OCCURRED. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE.  THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. LOCK PIN WAS NOT REMOVED. PROCEDURE WAS COMPLETED BY REMOVING STENT AND USING ANOTHER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266467 ↗
• MalfunctionOct 7, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 6FR NON-MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 40MM CALCIFIED AND FIBROUS LESION IN THE PATIENT¿S PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER REPORTED AS 6MM. MODERATE VESSEL CALCIFICATION AND NO TORTUOSITY ARE REPORTED. LESION EXHIBITED 50% STENOSIS. NO ISSUES WERE NOTED TO THE DEVICE 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. PRE-DILATION WAS PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE STENT WAS POSITIONED IN THE DESIRED LOCATION FOR DEPLOYMENT. THE RED RELEASE TAB WAS PULLED AND THEN THUMB WHEEL STARTED BEING TURNED PRIOR TO LOOKING UNDER FLUORO, STENT POSITION NOT CONFIRMED. ONCE FLUORO WAS ACTIVATED IT WAS NOTICED THAT STENT WAS NOT IN THE DESIRED LOCATION BUT LOCATED IN THE SHEATH. AT THIS POINT AT LEAST 50% OF STENT WAS DEPLOYED. THE PHYSICIAN WAS ADVISED TO DEPLOY THE REMAINING STENT, REMOVE DELIVERY SYSTEM WHILE MAINTAINING WIRE ACCESS, THEN REMOVE SHEATH WITH THE C

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

  MAUDE report 10642447 ↗
• MalfunctionJun 30, 2017Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST WITH A 7F SHEATH AND 035 GUIDEWIRE FOR TREATMENT OF AN 80MM SLIGHTLY TORTUOUS, SLIGHTLY CALCIFIED LESION IN DISTAL LOCATION IN THE COMMON ILIAC ARTERY OF DIAMETER 7MM WHICH EXHIBITED 60% STENOSIS. LESION WAS PRE-DILATED USING A 6X80 PRE-DILATION DEVICE. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS PREPPED AS PER IFU. THUMBSCREW/ LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THERE WAS NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT OR EXCESSIVE FORCE REQUIRED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. THE STENT DEPLOYED BUT "JUMPED" LEAVING PART OF THE DISSECTION UNCOVERED; A SECOND STENT (BALLOON MOUNTED) WAS THEN DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ABNORMALITIES REPORTED IN RELATION TO PATIENT ANATOMY - DISSECTION. THE DISSECTION OCCURRED DURING THE PRE-DILATION PROCESS - STENT WAS NOT RESPONSIBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6680249 ↗

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