EverFlex™ EVD35-06-040-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684051139), received between Mar 21, 2024 and Mar 21, 2024 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH A 7FR NON-MEDTRONIC SHEATH DURING TREATMENT OF PLAQUE LESION IN THE PATIENTS RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS BUT WAS OPENED VIA ATHERECTOMY AND BALLOON PRIOR TO STENT PLACEMENT. ARTERY DIAMETER REPORTED AS 4.5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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 IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. A SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE WAS USED. AN INPACT DRUG COATED BALLOON WAS USED FOR PRE-DILATION. A PACIFIC PLUS PTA BALLOON WAS USED FOR POST-DILATION. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED EVERFLEX STENT. THE STENT WAS BEING PLACED TO EXTEND AN ALREADY PLACED STENT. DIFFICULTY WAS NOTED DURING DEPLOYMENT. PHYSICIAN STARTED TO DEPLOY STENT WHEN RESISTANCE WAS ENCOUNTERED. IT WAS NOTED THAT THE LOCKING PIN (RED PIECE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948479 ↗

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