Skip to main content
DeviceWatchDeviceWatch
NIMClass 3

Stent, Carotid

FDA adverse event reports and recall history for stent, carotid (product code NIM), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
8,495
Deaths
691
Injuries
5,605
Malfunctions
2,157

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2026-06-05Open, ClassifiedComponent design/selection

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

    Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  • 2026-06-05Open, ClassifiedComponent design/selection

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

    Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  • 2026-06-05Open, ClassifiedComponent design/selection

    CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

    Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  • 2026-06-05Open, ClassifiedComponent design/selection

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

    Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  • 2026-06-05Open, ClassifiedComponent design/selection

    CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

    Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  • 2026-06-05Open, ClassifiedComponent design/selection

    CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

    Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  • 2025-10-10Open, ClassifiedDevice Design

    Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40

    Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.

  • 2025-08-08Open, ClassifiedProcess change control

    Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22; H749391508210 CAROTID WALLSTENT MONORAIL 8.0-21; H749391508290 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647010 CAROTID WALLSTENT MONORAIL 6.0-22; H965SCH647070 CAROTID WALLSTENT MONORAIL 8.0-21; H965SCH647080 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647090 CAROTID WALLSTENT MONORAIL 8.0-36; H965SCH647120 CAROTID WALLSTENT MONORAIL 10.0-24; H965SCH647130 CAROTID WALLSTENT MONORAIL 10.0-31; H965SCH647140 CAROTID WALLSTENT MONORAIL 10.0-37; M001719000 CAROTID WALLSTENT MR 6X22 5F 135CM; M001719010 CAROTID WALLSTENT MR 8X21 5F 135CM; M001719020 CAROTID WALLSTENT MR 8X29 5F 135CM; M001719030 CAROTID WALLSTENT MR 8X36 5F 135CM; M001719040 CAROTID WALLSTENT MR 10X24 5.9F 135CM; M001719050 CAROTID WALLSTENT MR 10X31 5.9F 135CM; M001719060 CAROTID WALLSTENT MR 10X37 5.9F 135CM;

    Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.

  • 2014-12-29TerminatedPackaging process control

    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 endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

    Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.

  • 2014-12-29TerminatedPackaging process control

    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 endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

    Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.

Monitor stent, carotid automatically

DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.

Start Free Trial