Protege RX SECX-10-40-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684038635), received between Jun 26, 2019 and Apr 23, 2025 — 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 23, 2025Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  A PHYSICIAN ATTEMPTED TO IMPLANT A PROTEGE RX STENT FOR THE TREATMENT OF A FIBROUS LESION IN THE PATIENT'S MID COMMON CAROTID ARTERY. MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WAS REPORTED. A 5MM SPIDER FX EMBOLIC PROTECTION DEVICE WAS USED. THE VESSEL WAS PRE-DILATED USING A 3.5MM DEVICE. IT WAS REPORTED THAT DURING STENT PLACEMENT, THE OUTER SHEATH WAS HARD AND COULD NOT BE PULLED OUT. IT WAS REMOVED ONCE AS IS AND A NEW ONE WAS OPENED AND INSERTED. THIS WAS ALSO HARD, BUT IT COULD BE DEPLOYED. THE FIRST ONE THAT WAS REMOVED WAS PULLED OUT SO HARD THAT IT DEPLOYED AND BROKE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889817 ↗
• MalfunctionJun 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN USED A PROTEGE RX STENT TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS, CALCIFIED LESION IN THE MID LEFT INTERNAL CAROTID-COMMON CAROTID ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED PER IFU WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH AND A MEDTRONIC GUARDWIRE WERE USED FOR THE PROCEDURE ALONG WITH GUARDWIRE AS EMBOLIC PROTECTION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT THERE WAS NO RESISTANCE ENCOUNTERED NOR EXCESSIVE FORCE USED DURING DELIVERY OF THE DEVICE TO THE LESION. APPROX 3MONTHS POST PROCEDURE, ON (B)(6) 2019, THE PATIENT RETURNED FOR A FOLLOW UP VISIT AND THE PHYSICIAN OBSERVED THAT THE STENT WAS INVERTED AND WAS SEEN AS ¿HEART SHAPED¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8734583 ↗

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