Protege RX SECX-8-60-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684038666), received between Sep 13, 2019 and Mar 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P060001); 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 18, 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.

• MalfunctionMar 9, 2023Premature Activation; Premature Activation

  A PROTÉGÉ RX SELF-EXPANDING STENT WAS INTENDED TO BE USED TO TREAT A LESION IN A PATIENT. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE STENT PRE-DEPLOYED IN THE CATHETER PRIOR TO REACHING THE TARGET LESION. THE PROCEDURE WAS COMPLETED BY REPLACING A NEW PRODUCT OF THE SAME SIZE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518559 ↗
• MalfunctionSep 13, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE PROTEGE RX ALONG WITH A NON MEDTRONIC 9FR (TERUMO) SHEATH, GUIDE WIRE AND A SPIDER FX EMBOLIC PROTECTION DEVICE. DEVICE WAS PREPARED ACCORDING TO IFU WITH NO ABNORMALITY. THE LESION WAS PRE DILATED USING A NON MEDTRONIC BALLOON. THERE WAS NO RESISTANCE WHEN DELIVERING THE DEVICE. IT WAS REPORTED THAT THE DEVICE ONLY PARTIALLY DEPLOY. THE MECHANISM OF THE DEPLOYMENT AND THE HANDLE OF THE EQUIPMENT WERE NOT DAMAGED BEFORE THE DEPLOYMENT FAILURE OCCURRED. THE DEVICE WHICH WAS DEPLOYED ABOUT 1CM WAS FORCIBLY PULLED INTO THE GUIDING CATHETER AND COLLECTED. THE STENT WAS NEVER IMPLANTED. WHEN DEPLOYING PROTÉGÉ RX, IT WAS QUITE HARD AND DIFFICULT TO BE RELEASED. THE OUTER SHEATH WAS PULLED WITH GREAT FORCE, THE STENT COULD BE DEPLOYED ABOUT 1 CM. HOWEVER, NO MATTER HOW MAY FORCES THE OUTER SHEATH WAS PULLED WITH, IT COULD NOT BE PULLED ANY FURTHER, AND THE STENT COULD NOT BE DEPLOYED ANY FURTHER. THE DEPLOYMENT WAS GIVEN UP, AND THE PROTEGE RX, WHICH HAD BEEN DEPLOYED ABOUT 1 CM, WAS PULLED LITTLE BY LITTLE INSIDE THE BLOOD VESSEL, AND IT WAS PUT INTO THE GUIDE CATHETER EVENTUALLY AND WAS RECOVERED.

  Patient problems: No Information

  MAUDE report 9037518 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060001. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2015 · Dec 4, 2014 · Terminated
  ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endartere
• Z-0879-2015 · Dec 4, 2014 · Terminated
  ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterect