EverFlex PRB35-07-080-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684069370), received between May 30, 2018 and Jul 18, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Expiration Issue” (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 18, 2019Fracture; Positioning Problem; Fracture; Positioning Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A PROTEGE EVERFLEX STENT TO TREAT A SLIGHTLY CALCIFIED, NON TORTUOUS LESION IN THE LEFT PROXIMAL COMMON ILIAC ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. A 6FR NON-MEDTRONIC SHEATH WAS USED FOR THE PROCEDURE WITH NO EMBOLIC PROTECTION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED OR FORCE APPLIED DURING DELIVERY OF THE DEVICE TO THE LESION. THE THUMBSCREW WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN COMPLETELY UNLOCKED THE STENT DEPLOYED IT VIA PIN AND PULL SYSTEM HOWEVER, APPROX. 1-2CM REMAINED UNDEPLOYED AND STUCK IN THE DEPLOYMENT SYSTEM. THE SHEATH WAS USED TO PUSH ON THE STENT TO TRY TO RELEASE THE REMAINING 1-2CM. THE STENT BECAME PUSHED INTO THE AORTA AND RESULTED IN MULTIPLE STENT FRACTURES. THE PATIENT IS SCHEDULED FOR ANOTHER PROCEDURE TO STENT AND REBUILD THE BIFURCATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8801824 ↗
• MalfunctionMay 30, 2018Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THAT AN EXPIRED MEDTRONIC EVERFLEX STENT WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7552203 ↗

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