Protégé™ GPS™ SERB65-12-60-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169729162), received between May 15, 2023 and May 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 15, 2023Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated

  A PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ GPS SELF-EXPANDING STENT WITH A 6FR SHEATH AND A 0.035 GUIDEWIRE DURING TREATMENT OF THE PATIENTS SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. IT IS REPORTED STENT DISLODGEMENT OCCURRED DURING SHEATH REMOVAL AND THAT A DEVICE COMPONENT DETACHED/CRACKED/FRACTURED DURING DELIVERY THROUGH THE VESSEL. THERE WAS ALSO DIFFICULTY REMOVING DEVICE PRIOR TO STENT DEPLOYMENT ALSO REPORTED. THE THE WHOLE SYSTEM WAS REMOVED. THE DETACHED PORTION OF DEVICE DOES NOT REMAIN IN PATIENT. AS THE STENT WAS DAMAGED, THE PROCEDURE WAS NOT CONTINUED WHICH LEAD TO EXTENDED PATIENT HOSPITALIZATION. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929149 ↗

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