Protege RX SECX-9-30-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684038574), received between Mar 29, 2023 and Jul 14, 2023 — classified as 2 injuries.

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.

• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE PROTÉGÉ RX CAROTID STENT WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY (L1). ON THE SAME DAY, POST PROCEDURE, THE PATIENT SUFFERED FROM A POST PROCEDURE HYPOTENSION AND BRADYCARDIA RESPONSE. THE EVENT WAS TREATED WITH MEDICATION. THE MEDICATION WAS LATER DISCONTINUED AFTER VITAL SIGNS IMPROVED. THE PATIENT WAS DISCHARGED. THE PATIENT RECOVERED.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 17323595 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE PROTÉGÉ STENT WAS USED TO TREAT THE LEFT COMMON ILIAC (L1). APPROXIMATELY 6 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM IN STENT RESTENOSIS OF THE LEFT INTERNAL CAROTID ARTERY. THE PATIENT WAS ASYMPTOMATIC. 70% OCCLUSION WAS NOTED TO THE LEFT CAROTID ARTERY ON THE FOLLOW UP DUPLEX ULTRASOUND. AN ANGIOGRAM WAS PERFORMED WHICH REVEALED 70% OCCLUSION TO THE MID STENT FROM THE ORIGINAL PROCEDURE. THE EVENT WAS TREATED WITH RE-STENTING. THE PATIENTS MEDICATION WAS ALSO ADJUSTED. THE PATIENT IS RECOVERING.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 16634371 ↗

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