Protégé™ GPS™ SERB65-09-60-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169728967), received between Oct 20, 2021 and Oct 20, 2021 — classified as 1 malfunction.

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.

• MalfunctionOct 20, 2021Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE THE PROTEGE GPS SELF EXPANDING STENT ALONG WITH A 6FR SHEATH DURING PROCEDURE TO TREAT LESION IN DISTAL RIGHT BILIARY ARTERY. THE VESSEL HAD MODERATE TORTUOSITY AND NO CALCIFICATION. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THERE WAS PARTIAL DEPLOYMENT. THERE WAS DAMAGE TO THE DEPLOYMENT MECHANISM/DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. HALF OF THE STENT WAS RELEASED BUT THEN A CLICK SOUNDED, AND THE DISTAL GRIP WAS UNLEARNED AND THE STENT REMAINED IN THE MIDDLE OF THE RELEASE. THE THUMBSWITCH WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED WHEN THE WHEEL WAS RELEASED TO PROCEED WITH THE RELEASE OF THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DISTAL HANDLE DETACHED AFTER RELEASING HALF, THE DISTAL HANDLE CLICKED AND RELEASED AND MANAGED TO FINISH THE RELEASE BY MAKING A GENTLE COUGHING MOVEMENT, BUT IT WAS NOT NORMAL. A PREVIOUS STENT HAD BEEN USED FOR THE OTHER SIDE AND IT WAS RELEASED WITHOUT INCONVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12663712 ↗

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