EverFlex™ EVD35-08-060-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684051283), received between Oct 10, 2018 and Feb 14, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2024Malposition of Device; Malposition of Device

  A PHYSICIAN WAS IMPLANTING AND EVERFLEX ENTRUST FOR TREATMENT OF AN UNKNOWN LESION IN THE LEFT COMMON ILIAC ARTERY. THE STENT DEPLOYED IN AN UNINTENDED LESION SITE. IT WAS REPORTED THE STENT DEPLOYED BACKWARD AND JUMPED FORWARD. THE PHYSICIAN EXTENDED THE STENT DISTALLY WITH ANOTHER STENT TO COVER THE LESION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18704296 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DISSECTED FEMORAL ARTERY DURING A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) WHICH REQUIRED THE IMPLANTATION OF A NON-MEDTRONIC CORONARY STENT AND 2 EVERFLEX ENTRUST STENTS IN THE ILIACS. IT WAS REPORTED THERE WAS NO ALLERGY OR SYMPTOMS PRESENT DURING THE PATIENT¿S STAY AT THE FACILITY WHERE THE STENTS WERE IMPLANTED. HOWEVER, MONTHS POST THE REPORTED PROCEDURE, THE PATIENT WAS EXPERIENCING SOME TYPE OF ALLERGIC REACTION. A SLIGHT RASH AND SKIN DISCOLORATION WERE REPORTED. THE PATIENT HAS BEEN PROVIDED WITH ALL OF THE STENT NAMES AND METALS ASSOCIATED WITH THE EVERFLEX STENTS. THE PATIENT HAS REPORTED ATTENDING A DERMATOLOGIST AND HAS REPORTED HAVING A BIOPSY CARRIED OUT ON THE RASH. THE RESULTS OF THE BIOPSY HAVE NOT YET BEEN REPORTED. IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY TREATMENT FOR THE REPORTED RASH.

  Patient problems: Reaction

  MAUDE report 7951617 ↗

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