EverFlex PRB35-08-040-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684069509), received between Jun 21, 2018 and Jul 24, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K060057, 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.

• MalfunctionJul 24, 2018Material Separation; Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS USING A PROTÉGÉ EVERFLEX FOR TREATMENT. NO ABNORMALITIES WERE NOTED IN RELATION TO PATIENT ANATOMY. NO ISSUES WERE NOTED DURING PREP. IT IS REPORTED THAT FOLLOWING DEPLOYMENT OF THE STENT WHEN THE PHYSICIAN WAS REMOVING THE DEVICE, THE INNER SHEATH CAME APART FROM THE DEVICE AND WAS ALMOST LEFT IN THE PATIENT. NO ADDITIONAL INTERVENTIONS WERE NEEDED TO REMOVE THE SHEATH. NO PATIENT INJURY WAS REPORTED. CASE WAS COMPLETED WITHOUT DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7713293 ↗
• MalfunctionJun 21, 2018Break; Detachment Of Device Component

  AFTER DEPLOYING THE STENT WHEN REMOVING DEVICE, THE INNER SHEATH CAME APART FROM THE DEVICE AND ALMOST LEFT INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7624622 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060057, 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
• Z-1598-2010 · Mar 31, 2010 · Terminated
  ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx on
• Z-0478-2010 · Nov 6, 2009 · Terminated
  Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, M