Protégé™ GPS™ SERB65-09-40-120Recalls & reported problems
Ev3, Inc · STENT SERB65-09-40-120 PROTEGE GPS V06 · Class 2 · Implant
All models of Protégé GPS (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169728943), received between Jan 23, 2025 and Jan 23, 2025 — classified as 1 death.
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.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 23, 2025Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component
IT WAS REPORTED WHILE ATTEMPTING TO DEPLOY THE PROTEGE GPS STENT, THE CATHETER BECAME LODGED WITH THE STENT PARTIALLY DEPLOYED. WHILE TRYING TO COMPLETELY DEPLOY AND DETACH FROM THE STENT, THE CATHETER FRACTURED LEAVING THE DISTAL END OF THE CATHETER LODGED IN THE PATIENT. ATTEMPTS TO REMOVE THE RETAINED PORTION OF THE CATHETER FROM THE PATIENT WERE NOT SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 21218136 ↗
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 · Terminatedev3, 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 · Terminatedev3 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
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- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
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- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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