Protege RX Tapered SECX-10-7-30-135Recalls & reported problems
Covidien LP · Carotid Stent System · Class 3 · Implant
All models of Protege RX Tapered (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684038710), received between Mar 29, 2017 and Mar 29, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
Device problems
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2017Material Deformation; Material Deformation
PHYSICIAN ATTEMPTED TO USE A PROTEGE RX SELF-EXPANDING STENT TO TREAT PATIENT IN THE RIGHT, PROXIMAL COMMON CAROTID ARTERY. LESION TYPE WAS CALCIFIED WITH SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 90% STENOSIS. ARTERY DIAMETER WAS 6 MM AND LESION LENGTH WAS 25 MM. A 4 MM BALLOON WAS USED TO PRE-DILATE. IT IS REPORTED THAT POST-STENT DEPLOYMENT, REMOVAL DIFFICULTIES WERE EXPERIENCED WITH THE DELIVERY SYSTEM DUE TO HEAVILY CALCIFIED INTERNAL CAROTID AND TORTUOSITY. THE DELIVERY CATHETER CAUGHT ON THE STENT CAUSING STENT DEFORMATION. A 0.035", 4 X 40 ADMIRAL BALLOON WAS USED TO DILATE THE STENT AND NEXT TO THE DELIVERY SYSTEM. BALLOON AND DEVICE WERE THEN REMOVED. NO PATIENT HISTORY REPORTED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6441919 ↗
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 · 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
- 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
Other STENT, CAROTID devices
- Neuroguard IEP® System NG-0740-140-2Contego Medical, Inc. · Stent, Carotid2 recalls32 reports
- Neuroguard IEP® System NG-NV-6-40Contego Medical, Inc. · Stent, Carotid2 recalls9 reports
- Neuroguard IEP® System NG-NV-7-40Contego Medical, Inc. · Stent, Carotid2 recalls8 reports
- ENROUTE Transcarotid Stent SR-0940-CSSilk Road Medical, Inc. · Stent, Carotid1 recall5 deaths58 reports
- Neuroguard IEP® System NG-0640-140-2Contego Medical, Inc. · Stent, Carotid2 recalls7 reports
- ENROUTE Transcarotid Stent SR-1040-CSSilk Road Medical, Inc. · Stent, Carotid1 recall3 deaths56 reports
- CGuard Prime Carotid Stent System CND0840Inspire M.D Ltd · Stent, Carotid1 recall1 death41 reports
- CGuard Prime Carotid Stent System CND0940Inspire M.D Ltd · Stent, Carotid1 recall31 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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