Protégé™ GPS™ SERB65-10-80-80 (UDI 00643169729094)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169729094), received between Aug 15, 2024 and Jan 9, 2026 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE STENT SERB65-10-80-80 PROTEGE GPS IN THE SUBCLAVIAN, CATHETER HANDLE SEPARATION OCCURRED (COMPLETELY DETACHED). THE LESION LENGTH WAS 60MM, AND A 6 FRENCH SHEATH AND NON MEDTRONIC GUIDEWIRE WERE USED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE HANDLE WAS CRACKED TO AID IN DEPLOYMENT AND THE STENT WAS DEPLOYED IN THE TARGET LOCATION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017980 ↗
• InjuryAug 15, 2024Fracture; Material Deformation; Fracture; Material Deformation

  ON (B)(6) 2024 PHYSICIAN IMPLANTED A PROTEGE GPS SELF-EXPANDING STENT DURING TREATMENT OF AN 80MM LESION IN THE PATIENTS LEFT PROXIMAL CEPHALIC SUBCLAVIAN VEIN. MODERATE VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 70% PLUS STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, (I.E. SHELF CARTON, HOOP/TRAY). NO ISSUES WERE 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. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. ON (B)(6) 2024 DURING DEVICE FOLLOW UP A FRACTURE WAS NOTED TO THE DEPLOYED STENT. A REPLACEMENT 10X80X80 MEDTRONIC STENT WAS PLACED OVER THE PROTÉGÉ STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19989438 ↗

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