EverFlex™ EVD35-07-080-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684051443), received between Jun 8, 2017 and Oct 19, 2023 — classified as 2 injuries, 1 malfunction.

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.

• InjuryOct 19, 2023Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  AN EVERFLEX ENTRUST WAS BEING IMPLANTED FOR THE TREATMENT OF A 70MM CALCIFIED FIBROUS LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. THE DEGREE OF OF TORTUOSITY WAS MILD AND CALCIFICATION WAS SEVERE. THE ARTERY DIAMETER WAS 7MM. A 6FR NON MEDTRONIC SHEATH AND A 014 NON MEDTRONIC GUIDEWIRE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A 6MM PRE-DILATION DEVICE WAS USED.  THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED. THE LOCK PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE AND THEN REMOVED PRIOR TO DEPLOYING. IT WAS REPORTED THERE WAS POOR GUIDEWIRE MOVEMENT DURING THE PROCEDURE. UPON ATTEMPT TO DEPLOY, THE STENT ADVANCED OUT OF THE DELIVERY CATHETER AND CRUMPLED UP. STENT DISLODGEMENT HAD OCCURRED AND 3CM WAS LENGTH OF THE STENT DEPLOYED. THE STENT WAS NOT REMOVED, NO ATTEMPTS WERE MADE TO RETRIEVE THE STENT. BALLOON DILATION WAS CARRIED OUT PROXIMAL TO THE DEPLOYED STENT. THE PHYSICIAN WAS ADVISED IN THE CASE TO EXCHANGE THE 014 GUIDEWIRE FOR A 035 GUIDEWIRE AS PER THE IFU. NO PATIENT INJURY WAS REPORTED. *

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17969967 ↗
• InjuryNov 14, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN USED AN EVERFLEX 7X80 MM SELF-EXPANDING STENT WITH ENTRUST DELIVERY SYSTEM TO TREAT A 60 MM MODERATELY CALCIFIED PLAQUE LESION IN THE DISTAL-LEFT COMMON ILIAC ARTERY. THE VESSEL WAS 7 MM IN DIAMETER AND WAS MODERATELY TORTUOUS. THE LESION HAD RESULTED IN 75% STENOSIS IN THE VESSEL. THE PROCEDURE USED A 7 FR 45 CM NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS PRE-DILATED USING A 6 MM PRE-DILATION DEVICE. THE EVERFLEX STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND THE PHYSICIAN ENCOUNTERED NO RESISTANCE DELIVERING THE DEVICE. IT WAS REPORTED THAT AFTER DEPLOYING THE STENT IN THE TARGET AREA, THE PHYSICIAN NOTICED THAT THE PROXIMAL PORTION OF THE STENT WAS NOT DEPLOYED PROPERLY BASED ON THE WAY THE END MARKERS LOOKED. IVUS WAS USED TO LOOK AT THE INSIDE AND WALL APPOSITION. A PTA BALLOON WAS EASILY PASS ED THROUGH THE STENT AND INFLATED. A NEW 8X40 EVERFLEX STENT WAS DEPLOYED AT THE PROXIMAL PORTION OF THE FIRST STENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7031962 ↗
• MalfunctionJun 8, 2017Inaccurate Delivery; Inaccurate Delivery

  THE PHYSICIAN USED AN EVERFLEX STENT WITH ENTRUST DELIVERY SYSTEM TO TREAT A SLIGHTLY TORTUOUS LESION LOCATED IN AN UNKNOWN VESSEL. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND PREPPED AS PER THE IFU WITH NO ISSUES NOTED ON INSPECTION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT ON DEPLOYMENT, THE STENT JUMPED FORWARD. THE STENT WAS LEFT IN THE POSITION THAT IT DEPLOYED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6626408 ↗

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