EverFlex™ EVD35-07-080-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684051689), received between Jul 2, 2026 and Jul 2, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJul 2, 2026Premature Activation; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY STENTING PROCEDURE USING THE EVERFLEX ENTRUST , THERE WAS DIFFICULTY ADVANCING THE STENT THROUGH THE CATHETER WHILE ATTEMPTING TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS PRE-DILATED WITH AN EVERCROSS 6 MM X 40 MM DEVICE, AND THE STENT SYSTEM WAS ADVANCED OVER A NITREX .035 400 CM GUIDEWIRE THROUGH A TERUMO 6 FR DESTINATION SHEATH. SEVERE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND EXCESSIVE FORCE WAS USED. THE OUTER SHEATH OF THE STENT CATHETER CRACKED AND SEPARATED FROM THE HANDLE DURING USE IN THE PATIENT. THE STENT PREMATURELY DEPLOYED WITHIN THE DESTINATION SHEATH RATHER THAN IN THE TARGET LOCATION, REMAINED WITHIN THE SHEATH WITHOUT MIGRATION, AND WAS REPORTED TO BE JAMMED AT THE END OF THE SHEATH AS OBSERVED UNDER FLUOROSCOPY. THE SHEATH WAS REMOVED FROM THE PATIENT DUE TO THE EVENT, AND THE DEVICE WAS REPORTED TO HAVE BEEN SAFELY REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 6 MM X 80 MM EVERFLEX DEVICE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY AND NO HEALTH CONSEQUENCES OR IMPACT. A CUT TO A MEDTRONIC EMPLOYEE WAS REPORTED WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688752 ↗

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