Protege RX SECX-9-40-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684038628), received between Nov 19, 2019 and Apr 28, 2020 — 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.

• MalfunctionApr 28, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  PHYSICIAN INTENDED TO USE A PROTÉGÉ RX SELF-EXPANDING STENT DURING TREATMENT OF THE PATIENT¿S CAROTID ARTERY. IT IS REPORTED THAT STENT JUMPING OCCURRED WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE PROTÉGÉ RX STENT WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10004337 ↗
• MalfunctionNov 19, 2019Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN USED A PROTEGE RX CAROTID STENT WITH A 9FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC EMBOLIC PROTECTION DEVICE DURING PATIENT TREATMENT. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM ITS PACKAGING. IFU WAS FOLLOWED. DEVICE PREPPED AS PER IFU. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. PRE-DILATION WAS PERFORMED USING A NON-MEDTRONIC BALLOON. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED. IT IS REPORTED WHEN PULLING THE OUTER SHEATH, THE STENT WAS UNABLE TO BE DEPLOYED DUE TO RESISTANCE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, BUT IT WAS NOTED ON REMOVAL THAT THE SHAFT WAS FRACTURED. THERE WERE NO WITHDRAWAL ISSUED EXPERIENCED AND ALL DEVICE COMPONENTS WERE REMOVED FROM THE PATIENT. INTERVENTION WAS NOT REQUIRED. A NON-MEDTRONIC STENT OF THE SAME SIZE WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9339773 ↗

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