EverFlex PRB35-08-060-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684069523), received between Oct 25, 2017 and Jul 13, 2018 — classified as 2 injuries.

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

• InjuryJul 13, 2018Misfire; Malposition of Device; Malposition of Device

  PHYSICIAN INTENDED TO USE A PROTÉGÉ EVERFLEX WITH A 6F NON-MDT SHEATH AND A STIFF ANGLED GUIDEWIRE FOR TREATMENT OF A 45MM PLAQUE LESION IN THE PATIENTS PROXIMAL LEFT EXTERNAL ILIAC OF DIAMETER 7MM. LESION EXHIBITED 70% STENOSIS. SLIGHT CALCIFICATION AND MODERATE TORTUOSITY WERE REPORTED. EMBOLIC PROTECTION WAS NOT USED. IFU WAS FOLLOWED. DEVICE WAS PREPPED WITHOUT ISSUE. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT IS REPORTED THE STENT DEPLOYED WITHIN A SHORT 10CM SHEATH. WHEN THE PHYSICIAN PULLED BACK THE SHEATH THE STENT DEPLOYED IN THE WRONG AREA (LEFT COMMON FEMORAL ARTERY) AND A QUARTER OF IT WAS NOT WITHIN THE ARTERY. A CUT-DOWN WAS PERFORMED TO REMOVE THE STENT FROM THE LEFT COMMON FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED AT THIS POINT. THE PATIENT IS DOING WELL.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 7684987 ↗
• InjuryOct 25, 2017Difficult to Remove; Difficult to Remove

  THE PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX SELF-EXPANDING TO TREAT A SEVERELY CALCIFIED 50 MM LESION IN THE LEFT COMMON ILIAC ARTERY. THE ARTERY WAS 7 MM IN DIAMETER AND SEVERELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A 0.035" NON-MEDTRONIC GUIDEWIRE. THE LESION WAS PRE-DILATED USING A 5X40 PTA BALLOON. THE PROTEGE EVERFLEX STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND THE PHYSICIAN WAS NOT MET WITH RESISTANCE DURING ADVANCEMENT. IT WAS REPORTED THAT FOLLOWING THE STENT DEPLOYMENT, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE DEVICE AND THE DELIVERY CATHETER WAS CAUGHT ON THE STENT UPON WITHDRAWAL. SURGICAL CUT DOWN WAS REQUIRED TO REMOVE THE DEVICE. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6978928 ↗

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