EverFlex™ EVD35-08-040-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684051276), received between Jun 7, 2018 and Jun 24, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2019Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN USED AN EVERFLEX ENTRUST WITH A 6FR X 55CM SHEATH AND 0.018 GUIDEWIRE DURING TREATMENT OF A 30MM CALCIFIED LESION IN THE PATIENT¿S COMMON ILIAC ARTERY OF DIAMETER 8MM. MODERATE TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. THE LESION EXHIBITED 60% STENOSIS. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT IS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/DEPLOYMENT. THE STENT WAS DEPLOYED. IT IS REPORTED THE DEPLOYMENT ISSUE LED TO THE STENT BUNCHING UP IN THE EXTERNAL ILIAC. THE PHYSICIAN POST-DILATED WITH A 8X40MM EVERCROSS BALLOON. POSSIBLY THE POST DILATATION BALLOON MIGHT HAVE CAUGHT ON AND MOVED THE STENT BUT THIS IS NOT CONFIRMED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8726794 ↗
• MalfunctionMar 20, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN WAS INTENDING TO USE AN EVERFLEX ENTRUST TO TREAT A 20MM PLAQUE LESION IN THE MID LEFT COMMON ILIAC ARTERY. THE 7MM DIAMETER VESSEL HAD LITTLE TORTUOSITY. A 5FR NON MEDTRONIC SHEATH WAS USED FOR THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES. THE LESION WAS PREDILATED USING A 7 X 20 DEVICE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT BUT NO RESISTANCE WAS ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. THE THUMBSWITCH/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE AND THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. IT WAS REPORTED THAT THE DEVICE PREMATURELY DEPLOYED IN VIVO DURING DELIVERY. THE RED PIN WAS PULLED AND A CLICK WAS HEARD AND IT WAS NOTICED THAT THE DEVICE HAD AUTOMATICALLY DEPLOYED THE STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436539 ↗
• MalfunctionJul 31, 2018Entrapment of Device; Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST TO TREAT A 40MM CALCIFIED CTO (CHRONIC TOTAL OCCLUSION - 100%) IN THE PATIENT¿S DISTAL RIGHT COMMON ILIAC ARTERY. THE VESSEL DIAMETER WAS REPORTED TO BE 7MM. A NON-MEDTRONIC 6F SHEATH AND A NON-MEDTRONIC 0.035 WIRE WERE USED. THE LESION WAS REPORTED TO BE OF MODERATE TORTUOSITY AND CALCIFICATION. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. EMBOLIC PROTECTION WAS NOT USED. PRE-DILATION WAS CARRIED OUT USING AN 8MM PRE-DILATION DEVICE. IT WAS REPORTED THAT DEPLOYMENT ISSUES OCCURRED WHEN THE RED SAFETY WAS PULLED PRIOR TO DEPLOYMENT - IT BECAME CAUGHT ON A WIRE AND THE STENT DEPLOYED ON ITS OWN. THE STENT WAS REPORTED TO HAVE DEPLOYED IN THE CORRECT AREA.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7734263 ↗
• MalfunctionJun 7, 2018Inaccurate Delivery; Defective Device; Inaccurate Delivery; Defective Device

  IT WAS REPORTED THAT THE PHYSICIAN USED AN EVERFLEX ENTRUST DEVICE WITH A 6F SHEATH AND NON-MDT .035 GUIDEWIRE FOR TREATMENT OF A FISTULA (CONCENTRIC WITH NO CALCIUM) IN A VENOUS AXILLARY VESSEL. IFU FOLLOWED AND DEVICE PREPPED WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE NO EXCESSIVE FORCE WAS USED. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT JUMPED FORWARD AND WAS REPORTED TO HAVE LANDED MIDWAY THROUGH THE LESION. THE PHYSICIAN STATED THAT WIRES WERE STICKING OUT OF THE AREA ON THE ENTRUST DELIVERY HANDLE WHEN HE REMOVED THE RED SAFETY PIN. HE DID NOT NOTICE THESE WIRES UNTIL AFTER THE STENT HAD BEEN DEPLOYED AND LOOKED AT THE DELIVERY SYSTEM. THE PHYSICIAN OPTED NOT TO PLACE A SECOND STENT AS THERE WAS NO FLOW DISRUPTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7577135 ↗

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