EverFlex™ EVD35-07-020-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684051412), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2024Premature Activation; Material Deformation; Premature Activation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH A 6FR NON-MEDTRONIC SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF 10MM PLAQUE LESION IN THE PATIENTS RIGHT MID COMMON ILIAC ARTERY. MINIMAL VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 7MM. LESION EXHIBITED 75% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LESION WAS NOT PRE OR POST DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. PRE-DEPLOYMENT ON THE WAY TO TARGET SITE WAS REPORTED. THE STENT REMAINS IN THE PATIENT AND NO ATTEMPTS WERE MADE TO REMOVE STENT. DEFORMATION WAS NOTED TO THE DEPLOYED STENT. ONE DISTAL MARKER OF THE FOUR LOOKS TO BE BENT BACK. THE DELIVERY SYSTEM WAS SAFELY REMOVED FROM PATIENT. NO ACTIONS TAKEN AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18931759 ↗

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