EverFlex™ EVD35-06-100-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00821684051375), received between Mar 23, 2017 and May 2, 2025 — classified as 3 injuries, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Premature Activation; Malposition of Device; Detachment of Device or Device Component; Premature Activation; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN INADVERTENT DEPLOYMENT OF A 6 X100 EVERFLEX ENTRUST SELF-EXPANDING STENT IN THE COMMON FEMORAL ARTERY EXTENDING INTO THE SUPERFICIAL FEMORAL ARTERY OCCURRED IN A PATIENT. THE DEPLOYMENT MECHANISM APPEARED TO BREAK. THE PATIENT REQUIRED HOSPITALIZATION AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21949283 ↗
• MalfunctionNov 22, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE EVERFLEX ENTRUST STENT, THE DEVICE WAS NEVER IMPLANTED DUE TO THE PHYSICIAN'S OBSERVATION THAT THE STENT CATHETER TIP APPEARED DIFFERENT THAN NORMAL UNDER ANGIOGRAPHY. THE STENT WAS NOT DEPLOYED. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. THE PROCEDURE WAS INTENDED FOR THE TREATMENT OF PLAQUE IN THE PROXIMAL LOCATION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, WHICH EXHIBITED MINIMAL TORTUOSITY AND CALCIFICATION. THE ARTERY DIAMETER WAS NOTED TO BE 5 MM. A 55 CM 6 FRENCH NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE WERE USED, AND THE VESSEL WAS PRE-DILATED WITH A 5 MM NANOCROSS DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE, SPECIFICALLY AN EVERFLEX ENTRUST 6-80. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755734 ↗
• MalfunctionNov 11, 2024Difficult to Remove; Difficult to Remove

  A PHYSICIAN IMPLANTED AN EVERFLEX ENTRUST FOR TREATMENT OF A PLAQUE LESION WITH 50% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY. THERE WAS MILD TORTUOSITY AND CALCIFICATION. THE LESION WAS PRE-DILATED WITH A 5X100MM PRE-DILATION DEVICE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THERE WAS DIFFICULTY REMOVING DEVICE FOLLOWING STENT DEPLOYMENT. THERE WAS NO RESISTANCE DURING ADVANCEMENT. NO PATIENT INJURY WAS REPORTED. UPDATE ON 26-FEB-2024: DELIVERY SYSTEM WAS REMOVED WITH SOME DIFFICULTY. THE STENT WAS DEPLOYED BUT TAIL END WAS GIVEN DIFFICULTY TO SPIN WHEEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652120 ↗
• InjuryFeb 28, 2024Fracture; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH A 45CM 5FR SHEATH DURING TREATMENT OF A PLAQUE LESION IN THE PATIENTS RIGHT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). NO VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. 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. A 4MM EVERCROSS BALLOON WAS USED FOR PRE-DILATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE SURGEON PLACED THE STENT OVER WIRE AND TO THE TARGET LESION AREA AND PULLED THE RED LOCKING PIN OFF THE DEVICE. THE SURGEON BEGAN TO DEPLOY THE STENT BY USING THE ROTATING THUMB WHEEL AND THE STENT BEGAN TO DEPLOY AND STOPPED DEPLOYING MID-WAY. THE ROTATING THUMB WHEEL WOULD NOT MOVE AND WAS STUCK. THE STENT WAS ONLY HALF DEPLOYED, SO THE SURGEON BROKE THE HANDLE INTO 2 PIECES, ONCE THE HANDLE WAS BROKEN, PARTS OF THE RED LOCKING PIN WERE VISIBLE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798621 ↗
• MalfunctionMay 5, 2023Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR AN ANGIOGRAM OF THE LEFT LEG WITH INTERVENTIONS. THE PHYSICIAN ATTEMPTED TO DEPLOY AN EVERFLEX ENTRUST SELF-EXPANDING STENT STNT AND THE STENT WOULD NOT DEPLOY. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT AND THE STENT BEGAN TO DEPLOY ON ITS OWN. THE PHYSICIAN HAD TO PLACE THE STENT IN THAT POSITION. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875875 ↗
• MalfunctionDec 8, 2020Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  PHYSICIAN USED AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A NON-MEDTRONIC 7FR SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE DURING TRE ATMENT OF A 150MM CALCIFIED LESION IN THE PATIENT¿S DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6-7MM. MODERATE VESSEL CALCIFICATION WAS REPORTED. LESION EXHIBITED 90-99% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE 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 USING A 4MM PRE-DILATION DEVICE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT DURING DELIVERY OF THE DEVICE, THE DISTAL PORTION OF THE STENT WAS DEPLOYED CORRECTLY BUT THE PROXIMAL PORTION SEPARATED AND WAS RETAINED BY THE DELIVERY DEVICE DESPITE THE THUMB WHEEL CONTINUING TO ROTATE. THE DEVICE CATHETER BECAME STUCK ON THE WIRE AND THE DEVICE AND WIRES MOVEMENTS CAUSED THE PROXIMAL SEGMENT OF THE STENT TO FRACTURE AND COMPLETELY SEPARATE. THE DETACHED PORTION REMAINS IN THE PATIENT. A SECOND EVERFLEX ENTRUST STENT WAS OPENED AND PREPPED AS PER IFU WITHOUT ISSUE. A 7FR SHEATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968111 ↗
• MalfunctionMar 5, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST WITH A 5F SHEATH DURING TREATMENT OF A 100MM CALCIFIED LESION IN THE PATIENT¿S MID AND DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) <(>&<)> POPLITEAL ARTERY (PA). MODERATE VESSEL CALCIFICATION REPORTED. VESSEL DIAMETER REPORTED AS 6MM. NO DAMAGE NOTED TO PACKAGING, NOR ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT WITHOUT ENCOUNTERING RESISTANCE. THE LOCK-PIN WAS REMOVED ONCE THE STENT WAS IN THE CORRECT LOCATION AND THE PHYSICIAN WAS READY TO DEPLOY. THERE WAS NO DAMAGE NOTED TO THE DEPLOYMENT MECHANISM OR DEVICE HANDLE. THE STENT ONLY DEPLOYED HALF-WAY AND STOPPED. THE PHYSICIAN CRACKED OPEN THE HANDLE TO MANUALLY PULL OUTER CATHETER AN RELEASE THE REMAINING PORTION OF THE STENT. THE STENT WAS SUCCESSFULLY DEPLOYED, AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9792847 ↗
• InjuryMay 9, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN WAS USING AN EVERFLEX ENTRUST WITH A 6MM SPIDERFX TO TREAT A CALCIFIED LESION WITH 90% STENOSIS IN THE MID/PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. THE LESION WAS PREDILATED USING A 5MM DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THAT THE STENT ONLY DEPLOYED HALFWAY AND THE PATIENT WAS TRANSFERRED TO HOSPITAL TO HAVE THE STENT SURGICALLY REMOVED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8594628 ↗
• MalfunctionMar 23, 2017Difficult to Remove; Difficult to Remove

  DURING AN ATTEMPT TO TREAT A LESION USING EVERFLEX ENTRUST, IT WAS REPORTED THAT PHYSICIAN EXPERIENCED DEPLOYMENT DIFFICULTY DURING WHILE ATTEMPTING TO DEPLOY STENT IN LESION AND ALSO REMOVAL DIFFICULTIES. DIFFICULTY REMOVING DEVICE PRIOR TO STENT DEPLOYMENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT ATTEMPT. PHYSICIAN CUT OUT SHEATH INSIDE WHERE SAFETY PIN GOES IN ORDER TO SLIDE OFF WIRE, ANOTHER ENTRUST WAS PULLED OFF THE SHELF WHICH DEPLOYED PROPERLY TO COMPLETE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6429230 ↗

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