EverFlex™ EVD35-07-100-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684051696), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Premature Activation” (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.

• InjuryApr 30, 2025Premature Activation; Premature Activation

  PHYSICIAN WAS ATTEMPTING TO USE A EVERFLEX ENTRUST 7X100X150 IN THE SUPERFICIAL FEMORAL ARTERY, PROXIMAL MID DISTAL PERIPHERAL ARTERY(S). CALCIFIED AND PLAQUE LESION, MINIMAL TORTUOSITY AND MODERATE CALCIFICATION. 70-90 % LESION STENOSIS, LESION LENGTH 200MM AND A RTERY/VEIN DIAMETER 5-6MM. A 5FR SHEATH WITH A 035 BENSON GW WAS USED. IFU WAS FOLLOWED. EMBOLIC PROTECTION WAS NOT USED, THE VESSEL WAS PRE-DILATED WITH BARD DILATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUN TERED WHEN ADVANCING THE DEVICE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. IT WAS REPORTED THAT THERE WAS DEPLOYMENT ISSUES, THE STENT PRE-DEPLOYMENT (ON WAY TO TARGET SITE) IN THE PATIENT. PARTIAL DEPLOYMENT, 75% OF THE STENT DEPLOYED AND THE DISTAL PART OF THE STENT GOT STUCK IN THE INNER SHEATH AND WOULD NOT RELEASE THE STENT. PHYSICIAN ENDED UP USING FORCE AND PULLED THE STENT CATHETER OUT THROUGH THE 5FR SHEATH. THE TIP OF THE STENT SHEARED OFF. ATTEMPTS WERE MADE TO REMOVE THE STENT BUT REMAINS IN THE PATIENT. NO DEFORMATION NOTED TO THE DEPLOYED STENT AND THE DELIVERY SYSTEM WAS SAFELY REMOVED. NO OTHER ACTIONS TAKEN AS A RESU

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934446 ↗

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