Protégé™ GPS™ SERB65-10-80-120 (UDI 00643169729087)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169729087), received between Mar 4, 2025 and Apr 3, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryApr 3, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE USING THE PROTEGE GPS STENT SYSTEM IN THE EXTERNAL ILIAC ARTERY, THERE WAS A 10-MINUTE DELAY IN SURGERY DUE TO PRODUCT ISSUES. REMOVAL DIFFICULTIES WERE REPORTED WHEN THE STENT SYSTEM TIP RETRACTED INTO THE SHEATH, AND THE STENT SYSTEM REQUIRED SNARING FOR REMOVAL. THE LESION LENGTH WAS REPORTED AS 70 MM AND THE ARTERY/VEIN DIAMETER AS 9 MM. THE VESSEL WAS POST-DILATED. THE STENT SYSTEM WAS REPORTED TO HAVE BEEN SAFELY REMOVED, AND NO VESSEL DAMAGE WAS REPORTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776068 ↗
• MalfunctionMar 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN EXPIRED STENT, SPECIFICALLY A PROTEGE GPS STENT, WAS IMPLANTED IN A PATIENT. THE PROCEDURE WAS COMPLETED AND THE DEVICE REMAINS IN SERVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512881 ↗

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