EverFlex™ EVD35-07-060-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684051214), received between May 16, 2025 and May 16, 2025 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2025Premature Activation; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Premature Activation; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN EVERFLEX ENTRUST STENT IN THE RIGHT COMMON ILIAC ARTERY, SEVERE RESISTANCE WAS FELT BY THE PHYSICIAN, AND THE DELIVERY SYSTEM COULD NOT BE ADVANCED TO THE TARGET LESION. A NON MEDTRONIC SHEATH AND GUIDEWIRE WERE USED. THE TARGET LESION WAS A CALCIFIED LESION IN THE DISTAL REGION OF THE RIGHT ILIAC ARTERY. THE ARTERY WAS 7MM IN DIAMETER WITH SEVERE TORTUOSITY AND MODERATE CALCIFICATION. THE PHYSICIAN ATTEMPTED TO ADVANCE. THE STENT PREMATURELY DEPLOYED WITHOUT THE REMOVAL OF THE RED SAFETY, LOCKING MECHANISM, OR TURNING THE THUMB WHEEL. THE PHYSICIAN NAVIGATED A BALLOON TO DEPLOY THE STENT IN THE ARTERY, BUT DISLODGEMENT AND ELONGATION OF THE STENT WERE NOTED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, WHICH WAS NOT A MEDTRONIC DEVICE. THE VESSEL WAS PRE-DILATED WITH AN EVERCROSS .035 5 X 100 DILATION DEVICE, AND POST-DILATION WAS PERFORMED. THE STENT REMAINS IN THE PATIENT, AND NO ATTEMPTS WERE MADE TO REMOVE IT. THE PHYSICIAN WAS ABLE TO FULLY DEPLOY THE STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22034996 ↗

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