EverFlex PRB35-06-080-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684069202), received between Dec 7, 2017 and Dec 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Accessory Incompatible” (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.

• MalfunctionDec 7, 2017Accessory Incompatible; Break; Accessory Incompatible; Break

  THE PATIENT HAD A PREVIOUS PTA IN THE RIGHT COMMON ILIAC ARTERY WITH AN UNKNOWN DEVICE, DURING A FOLLOW-UP CHECK THE ANGIOGRAM SHOWED A SMALL DISSECTION IN THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN INTENDED TO USE THE PROTÉGÉ EVERFLEX TO TREAT THE DISSECTION IN THE COMMON ILIAC ARTERY AS PER IFU. IT WAS REPORTED THE VESSEL WAS PRE-DILATED. THE STENT WAS LOADED ON A 0.035¿ GUIDEWIRE, AND WAS ADVANCED THROUGH A 6FR SHEATH. THE DEVICE BECAME STUCK IN THE SHEATH, A SECOND ATTEMPT WAS MADE TO ADVANCE THE DEVICE UNSUCCESSFULLY. THE 0.035¿ GUIDEWIRE WAS CHANGED FOR ANOTHER 0.035 GUIDEWIRE, THE SAME ADVANCEMENT ISSUES REMAINED. THE PHYSICIAN PULLED BACK THE DELIVERY SYSTEM AND OBSERVED A BREAK IN THE SHAFT, THE STENT WAS NOT MOUNTED ON IT. THE PHYSICIAN PULLED BACK THE SHEATH, CUTTING IT WITH A KNIFE, REVEALING THE STENT INSIDE THE SHEATH. PHYSICIAN DECIDED NOT TO STENT THE PATIENT AS THE BLOOD FLOW WAS GOOD. NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7091467 ↗

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