Protégé™ GPS™ SERB65-10-40-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169729049), received between Jan 31, 2023 and Apr 3, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY PROCEDURE A PROTEGE GPS STENT WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY (PROXIMAL AND MID SEGMENTS) FOR A TARGET LESION DESCRIBED AS 30MM PLAQUE LESION WITH MINIMAL TORTUOSITY, MINIMAL CALCIFICATION, AND A VESSEL DIAMETER OF 9 MM. THE STENT WAS PLACED BEFORE THE EXPIRATION DATE WAS CHECKED, AND IT WAS THEN IDENTIFIED THAT THE DEVICE WAS EXPIRED. THE VESSEL WAS PRE-DILATED AND POST-DILATED, NO EMBOLIC PROTECTION WAS USED, NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO PACKAGING OR DEVICE REMOVAL ISSUES WERE REPORTED. THE DEVICE WAS USED IN THE PATIENT AND REMAINED IMPLANTED, AND THE PROCEDURE WAS REPORTED TO HAVE PROCEEDED AS NORMAL. NO INJURY, INTERVENTION, OR HEALTH CONSEQUENCES WERE REPORTED, AND THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774696 ↗
• MalfunctionSep 27, 2024Premature Activation; Premature Activation

  PHYSICIAN ATTEMPTED TO USE A PROTEGE GPS SELF-EXPANDING STENT WITH A 45 CM 6 FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A 30 MM CALCIFIED LESION IN THE PATIENTS RIGHT DISTAL COMMON ILIAC ARTERY. SEVERE VESSEL CALCIFICATION WAS REPORTED. LESION EXHIBITED 70% STENOSIS. ARTERY DIAMETER REPORTED AS 10 MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NARROWING WAS AT THE DISTAL END OF A VERY SHORT COMMON ILIAC WITH CALCIFICATION AND SEVERE NARROWING OF THE RIGHT INTERNAL ILIAC ARTERY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THE STENT DEPLOYED PREMATURELY INSIDE OF THE ACCESS SHEATH AS THE SYSTEM WAS BEING ADVANCED TO THE LESION SITE AND REMAINED INSIDE THE SHEATH. THE STENT DOES NOT REMAIN IN THE PATIENT. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320197 ↗
• MalfunctionJan 31, 2023Premature Activation; Premature Activation

  A PROTÉGÉ GPS WAS INTENDED TO BE IMPLANTED FOR THE TREATMENT OF AN UNKNOWN LESION IN THE MID LEFT REGION OF THE COMMON ILIAC ARTERY. A 7FR SHEATH AND NON MDT GUIDEWIRE WERE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 9MM X 30 PRE-DILATION DEVICES. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT. THE LOCK PIN WAS NOT REMOVED JUST LOOSENED PRIOR TO DEPLOYMENT. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND THEN FROZE ON THE WIRE. STENT DEPLOYED ON WIRE PRIOR TO INSERT IN PATIENT. THE WHOLE SYSTEM PARTIALLY DEPLOYED, AND THE WIRE WAS REMOVED FROM THE PATIENT THROUGH THE SHEATH AND THE CASE WAS FINISHED WITH A BALLOON ANGIOPLASTY. NO VESSEL DAMAGE REPORTED, AND NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271335 ↗

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