Protégé™ GPS™ SERB65-12-60-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169729179), received between Jun 2, 2020 and Apr 14, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2022Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ GPS SELF-EXPANDING STENT DURING PROCEDURE TO TREAT A FIBROUS LESION IN THE LEFT MID SUBCLAVIAN VEIN WITH 50% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. STENT DEFORMATION OCCURRED IN VIVO POST DEPLOYMENT. THE 80MM STENT ROLLED IN ON ITSELF AND INACCURATELY DELIVERED TO AN UNINTENDED LESION SITE. IT IS UNKNOWN IF THERE WAS ENOUGH LANDING ZONE. THE LESION WAS PRE DILATED WITH A 60MM DEVICE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT WITH NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THERE WAS A FRACTURED STENT EXISTING IN THE PATIENT. PROTÉGÉ GPS STENT WAS DEPLOYED IN THE FRACTURED STENT. AFTER DEPLOYMENT, FLURO SHOWED THAT THE STENT HAD TRAVELLED PROXIMAL AND ROLLED IN ON ITSELF. THERE WAS NO COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110144 ↗
• MalfunctionDec 13, 2021Activation Failure

  PROTÉGÉ GPS SELF EXPANDING PERIPHERAL STENT SYSTEM DID NOT DEPLOY FROM SYSTEM. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13002438 ↗
• MalfunctionDec 18, 2020Use of Device Problem; Use of Device Problem

  PHYSICIAN USED A PROTÉGÉ GPS SELF-EXPANDING STENT DURING TREATMENT OF A FISTULA. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PREPPED WITHOUT ISSUE. THE STENT WAS DEPLOYED SUCCESSFULLY WITHOUT ISSUE. POST IMPLANT IT WAS REPORTED THAT THE STENT WAS IMPLANTED POST-EXPIRY. NO ADVERSE EVENT HAS BEEN REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11035984 ↗
• InjuryJun 2, 2020Fracture; Material Deformation; Fracture; Material Deformation

  PHYSICIAN INTENDED TO USE A PROTEGE GPS SELF-EXPANDING STENT SYSTEM WITH A NON-MEDTRONIC 7FR SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 40MM PLAQUE LESION IN THE PATIENT¿S MID RIGHT CEPHALIC VEIN OF DIAMETER 11MM. MODERATE VESSEL TORTUOSITY AND SLIGHT CALCIFICATION ARE REPORTED. NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE LESION WAS NOT PRE-DILATED. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED FOLLOWING DEPLOYMENT OF THE STENT, A FRACTURE WAS NOTED DURING VISUAL EXAMINATION. THE FRACTURED STENT WAS LINED WITH A NON-MEDTRONIC COVERED STENT. THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10108413 ↗

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-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
• 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