Protege RX SECX-6-30-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684038543), received between May 28, 2021 and May 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling 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 28, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  PHYSICIAN USED A PROTÉGÉ RX SELF-EXPANDING STENT WITH A SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 30MM PLAQUE LESION IN THE PATIENT¿S COMMON CAROTID ARTERY. ARTERY DIAMETER REPORTED AS 6MM. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). AFTER OPENING THE PACKAGING, IT IS REPORTED THE PHYSICIAN ATTEMPTED TO USE A 6X30 STENT WHICH THE BOX AND PACKAGING WAS LABELLED WITH, HOWEVER WHEN THE DEVICE WAS CHECKED THE HUB WAS LABELLED WITH 6X40. THE DEVICE WAS PREPPED WITHOUT ISSUE AND USED DESPITE THE LABELLING MISMATCH. THE PHYSICIAN ASSESSED THE DEVICE ON X-RAY AND IT LOOKED LIKE A 6X30. NO ISSUES NOTED DURING THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900462 ↗

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