CGuard Prime Carotid Stent System CND1030Recalls & reported problems
Inspire M.D Ltd · CGuard Prime Carotid Stent System 135cm,10mmx30mm · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290120281776), received between Jul 28, 2026 and Jul 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
5 other recalls cover devices cleared under the same FDA submission (P240029); 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
Recalls naming this device
- May 1, 2026Class IIOpen, Classified
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Z-2329-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Activation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059219 ↗MalfunctionJul 28, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059216 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P240029. One submission often covers many models, so check the product and lot details in each record.
- Z-2327-2026 · May 1, 2026 · Open, ClassifiedCGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
- Z-2328-2026 · May 1, 2026 · Open, ClassifiedBrand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
- Z-2326-2026 · May 1, 2026 · Open, ClassifiedBrand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
- Z-2325-2026 · May 1, 2026 · Open, ClassifiedBrand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
- Z-2330-2026 · May 1, 2026 · Open, ClassifiedCGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
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 · each recall links to the FDA recall notice
- 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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