EverFlex PRB35-06-120-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684069240), received between Mar 13, 2019 and Mar 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EF SELF-EXPANDING STENT TO TREAT A 400MM FIBROUS LESION WITH MODERATE CALCIFICATION AND 90% STENOSIS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE TORTUOSITY WAS REPORTED. ARTERY DIAMETER WAS 6MM. A NON-MEDTRONIC 6FR 45CM SHEATH AND A NON-MEDTRONIC GLIDEWIRE 0.35 X 260 SHEATH WERE USED IN THIS PROCEDURE. NO EMBOLIC PROTECTION WAS USED, NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY), NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED, THE LESION WAS PRE-DILATED WITH AN IN.PACT ADMIRAL (5X200). THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. THE STENT WAS PLACED WITHOUT ANY PROBLEMS AND POST DILATED WITH A 6X200 A NON MEDTRONIC (BSC CHARGER) BALLOON. IT WAS REPORTED THAT THE STENT WAS IMPLANTED 3 DAYS POST EXPIRY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417252 ↗

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