EverFlex™ EVD35-06-120-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684051627), received between Oct 23, 2018 and Jun 19, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX STENT. THE IFU WAS FOLLOWED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. IT WAS REPORTED THE STENT STARTED TO DEPLOY AND THEN WOULD NO LONGER RELEASE. ATTEMPT WAS MADE TO REMOVE STENT AND DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS SAFELY REMOVED BUT ART OF THE STENT WAS LEFT BEHIND WHEN PULLED BACK INTO COMMON FEMORAL/SHEATH SITE. THE STENT WAS FULLY EXPLANTED ON THE FOLLOWING DAY ((B)(6) 2023).

  Patient problems: Insufficient Information

  MAUDE report 17152096 ↗
• InjuryFeb 6, 2019Material Deformation; Material Deformation

  PHYSICIAN USED AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 6FR NON-MEDTRONIC (COOK ANSEL) SHEATH AND 0.035 WHOLEY WIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS PROXIMAL AND MID LEFT EXTERNAL ILIAC TO LEFT COMMON FEMORAL ARTERY. SLIGHT TORTUOUS AND MODERATE CALCIFICATION IS REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. PRE-DILATION WAS PERFORMED USING A 5X40 PRE-DILATION DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. IT IS REPORTED FOLLOWING DEPLOYMENT OF APPROX. 2CM OF THE STENT IT JUMPED DRAMATICALLY. THE 120MM STENT APPEARED TO BE ONLY 80MM WHEN DEPLOYED. THE STENT WAS POST DILATED AND A SECOND STENT WAS DEPLOYED WITHOUT DIFFICULTY. NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8309591 ↗
• InjuryOct 23, 2018Stretched; Difficult or Delayed Activation; Stretched; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING TREATMENT OF MODERATELY CALCIFIED FIBROUS LESIONS WITH 80% STENOSIS IN THE DISTAL MID LEFT SUPERFICIAL FEMORAL ARTERY (ARTERY DIAMETER 6MM), PHYSICIAN FIRST PREPPED TWO LESIONS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE AND THEN POST DILATED WITH TWO IN.PACT ADMIRAL BALLOONS. FOLLOWING POST-DILATION, A DISSECTION WAS NOTED IN THE DISTAL SFA AND POPLITEAL ARTERY THAT WAS DETERMINED TO REQUIRE STENTING. THE PHYSICIAN THEN USED AN EVERFLEX ENTRUST WITH A NON-MEDTRONIC 7FR. 55CM SHEATH AND A SPIDER FX 7MM EMBOLIC PROTECTION DEVICE. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING DEPLOYMENT. THE LENGTH OF THE DEPLOYED STENT WAS 6X120MM AND WAS ELONGATED TO 210MM. ONCE THE STENT WAS PROPERLY POSITIONED FOR DEPLOYMENT THE RED TAB WAS FULLY PULLED AND THE DEPLOYMENT WHEEL WAS THEN TURNED TO DEPLOY. THE PHYSICIAN THEN FELT RESISTANCE IN THE WHEEL AFTER ONLY A FEW TURNS AND WAS UNABLE TO DEPLOY THE STENT FURTHER. THE WHEEL HAD JAMMED. THE PHYSICIAN DISASSEMBLED THE DELIVERY SYSTEM TO FIND THE DELIVERY WHEEL HAD BECOME ENTANGLED WITH THE IN

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7994375 ↗

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