EverFlex™ EVD35-08-040-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684051740), received between May 16, 2018 and Mar 5, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EVERFLEX ENTRUST TO TREAT A FIBROUS LESION IN THE MID RIGHT ILIAC ARTERY. DEGREE OF TORTUOSITY WAS MINIMAL. DEGREE OF CALCIFICATION WAS MODERATE. LESION STENOSIS WAS 80%. A 6F TERUMO DESTINATION WAS USED. A .035 STIFF GLIDE WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. A MEDTRONIC EVERFLEX 8X60 PTA WAS USED AS INFLATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IFU WAS FOLLOWED WITHOUT ISSUE. AN EXPIRED PRODUCT WAS IMPLANTED IN THE PATIENT. THE DELIVERY DEVICE WAS REMOVED. THE CIRCULATOR OPENED THE STENT AND PROVIDED IT TO THE SCRUB ASSISTANT WHO PROVIDED IT TO THE PHYSICIAN WITHOUT VERIFYING THE EXPIRATION DATE. THE STENT WAS IMPLANTED IN THE RIGHT DISTAL COMMON ILIAC ARTERY WITH SMALL PORTION EXTENDING INTO THE EXTERNAL ILIAC REGION. NO PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837103 ↗
• InjuryMay 16, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST DEVICE TO TREAT STENOSIS IN THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN REPORTED THAT WHEN SHE WAS READY TO DEPLOY THE STENT IT JUMPED OFF RESULTING IN POOR PLACEMENT APPROXIMATELY 2CM PROXIMAL TO THE INTENDED SITE. THE STENT REMAINS IN THE PATIENT AND ANOTHER STENT WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7517626 ↗

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