Protege RX SECX-6-60-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684038642), received between May 19, 2023 and May 19, 2023 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PROTÉGÉ RX WAS INTENDED TO BE USED FOR THE TREATMENT OF A LESION IN THE COMMON CAROTID ARTERY. A 6FR NON MEDTRONIC SHEATH WAS USED. THE DEVICE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE DURING DELIVERY TO THE LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LOCK PIN WAS CHECKED FOR SECUREMENT. .THE LESION WAS PRE-DILATED. IT WAS REPORTED THE DEVICE WAS UNABLE TO DEPLOY. THE THUMBSCREW/LOCK-PIN WAS OPENED PRIOR TO ATTEMPTED DEPLOYMENT. NO INTERVENTION WAS NEEDED TO REMOVE THE DEVICE IT WAS REMOVED FROM THE SHEATH AND REMOVED WITHOUT INCIDENT FROM THE PATIENT. STRUTS WERE VISIBLE AFTER DEVICE WAS REMOVED FROM SHEATH. ANOTHER STENT WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960308 ↗

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-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
• 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