EverFlex™ EVD35-08-150-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684051795), received between Apr 12, 2018 and Jan 31, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

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

• MalfunctionJan 31, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 80% STENOSIS. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. PRE-DILATION WAS PERFORMED USING A SIZE 7 PE-DILATION DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. DEPLOYMENT DIFFICULTIES WERE NOTED. DURING DEPLOYMENT OF THE STENT, THE PHYSICIAN ROLLED THE DEVICE AND IT LOOKED AS IF THE STENT CAME OFF BUT DID NOT EXPAND. IT WAS DIFFICULT TO VISUALISE BUT APPEARED AS IF THE STENT DID NOT COME OFF THE SHAFT. THE PHYSICIAN THEN ROLLED THE DEVICE ALL THE WAY BACK AND DEPLOYED THE STENT, BUT IT DID NOT EXPAND. THE DELIVERY CATHETER WAS REMOVED, AND A BALLOON WAS SUCCESSFULLY USED TO EXPAND THE STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9652467 ↗
• MalfunctionApr 12, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST DEVICE WITH A NON-MDT 7F SHEATH AND A NON-MDT 0.035" GUIDEWIRE FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION IN THE PROXIMAL/MID/DISTAL RIGHT EXTERNAL/COMMON ILIAC ARTERY. THE LESION WAS 120MM IN LENGTH AND DESCRIBED AS 100% STENOSED, PRE-DILATION, AND 80% STENOSED, POST DILATION. PRE-DILATION WAS CARRIED OUT USING THE FOLLOWING DEVICES: NANOCROSS 3MMX60MM, NANOCROSS 4MMX150MM & AN EVERCROSS 6MMX80MM. THE VESSEL WAS 8MM IN DIAMETER. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED. IT WAS REPORTED THE DEVICE WAS ADVANCED TO THE DESIRED LOCATION IN THE RIGHT EXTERNAL ILIAC (TARGET LESION) PASSING THROUGH A PREVIOUSLY DEPLOYED STENT WITHOUT RESISTANCE. THE PHYSICIAN THEN PULLED BACK ON THE DELIVERY SYSTEM UNTIL NO SLACK WAS NOTED. THE SAFETY LOCKING PIN WAS REMOVED. THE PHYSICIAN THEN CHECKED THE SLACK ON THE STENT AGAIN AND THE SILVER RETRACTABLE OUTER SHEATH CAUGHT ONTO THE GOLD ISOLATION SHEATH AND WRAPPED AROUND ITSELF. THE STENT AND THE DELIVERY SYSTEM, AS A WHOLE UNIT, WAS THEN REMOVED. UPON REMOVAL OF THE STENT IT WAS NOTED THAT THE STENT HAD BECOME PARTIALLY DEPLOYED. PROT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7425560 ↗

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