Protégé™ GPS™ SERB65-09-80-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169728998), received between Jun 8, 2020 and Jun 8, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2020Fracture; Premature Activation; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Premature Activation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN INTENDED TO USE A PROTEGE GPS SELF-EXPANDING STENT SYSTEM WITH A 6FR NON-MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A SOFT TISSUE, 80MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID LEFT COMMON ILIAC ARTERY OF DIAMETER 8MM. SLIGHT VESSEL TORTUOSITY IS REPORTED. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE LESION WAS PRE-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED DEPLOYMENT DIFFICULTIES WERE NOTED. NO DAMAGE WAS NOTED TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. THE LOCK-PIN HAD BEEN REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. A PARTIAL DEPLOYMENT IS REPORTED. TWO KISSING NON-MEDTRONIC BALLOON EXPANDABLE STENTS WERE DEPLOYED AND THE PROTEGE GPS STENT WAS RETRACTED TO THE BIFURCATION WITH HALF IN THE LEFT ILIAC AND HALF IN THE RIGHT. THE 2 KISSING STENTS WERE PLACED THROUGH THE INTERSTICES OF THE STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127668 ↗

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