EverFlex™ EVD35-08-060-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684051757), received between Sep 8, 2020 and Sep 8, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionSep 8, 2020Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  PREMATURE DEPLOYMENT OF INTRAVASCULAR STENT. AN 8X60MM EVERFLEX STENT WAS BEING USED TO TREAT DUAL SINUS STENOSIS CAUSING SYMPTOMATIC IDIOPATHIC INTRACRANIAL HYPERTENSION (PSEUDOTUMOR CEREBRI). THIS WAS OFF LABEL USE, AS THERE IS NO STENT CURRENTLY APPROVED FOR THIS PURPOSE. THE STENT DELIVERY SYSTEM WAS ADVANCED TO THE JUGULAR BULB BUT COULD NOT BE ADVANCE FURTHER TO THE INTENDED SITE AT THE TRANSVERSE-SIGMOID SINUS JUNCTION DUE TO ANGULATION AT THE JUGULAR BULB. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE STENT USING 0.035" GUIDE WIRE AND STIFF GUIDE WIRE. BUT AFTER THESE WERE UNSUCCESSFUL, THE DELIVERY SYSTEM WAS REMOVED AT THIS POINT. IT WAS NOTED THAT THE STENT HAD DEPLOYED IN THE DISTAL SIGMOID SINUS AND PROXIMAL JUGULAR VEIN DESPITE THE FACT THAT THE SAFETY HAD NOT BEEN RELEASED, AND THE ROTATING THUMB WHEEL USED TO CONTROL STENT DEPLOYED HAD NOT BEEN TOUCHED. UPON NOTING THAT THE STENT HAD PREMATURELY DEPLOYED, THE DELIVERY SYSTEM WAS INSPECTED, AND THERE WAS NO EVIDENCE OF CRIMPING, KINKING AN OTHER TRAUMA TO THE DEVICE. A SECOND 8X60MM EVERFLEX STENT WAS DEPLOYED WITHOUT DIFFICULTY AT THE INTENDED SITE AFTER OBTAINING MORE DISTAL PURCHASE WITH THE GUIDING SHEATH. THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10502288 ↗

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