CGuard Prime Carotid Stent System CND0940Recalls & reported problems
Inspire M.D Ltd · CGuard Prime Carotid Stent System 135cm, 9mmx40mm · 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.
Quick summary
This InspireMD CGuard Prime carotid stent is a wire-mesh implant that props open narrowed carotid arteries in the neck. The 35 reports filed since October 2025 mostly describe the stent failing to open or release properly during placement. There are no deaths and no injuries. One recall, started in May 2026 and still open, says the delivery system can meet high resistance during deployment and leave the stent unable to expand. Reports rose sharply, from 1 in the prior 12 months to 34 in the latest.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07290120281745), received between Oct 23, 2025 and Aug 31, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (17 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-2328-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Activation Failure17
- Insufficient Device Problem Information8
- Difficult or Delayed Activation4
- Activation, Positioning or Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions31
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50529047 ↗MalfunctionAug 29, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50510080 ↗MalfunctionAug 29, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50510070 ↗MalfunctionAug 28, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509706 ↗MalfunctionAug 28, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509456 ↗MalfunctionJul 28, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50048331 ↗MalfunctionJul 28, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50048330 ↗MalfunctionJul 27, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037168 ↗MalfunctionJul 27, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037167 ↗MalfunctionJul 27, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037166 ↗MalfunctionJul 27, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037165 ↗MalfunctionJul 27, 2026Activation Failure
It was reported that during an elective stenting procedure, the CGuard prime stent would not deploy. A secondary third party (Abbott Xact) stent was deployed successfully. There was no patient injury or adverse clinical outcome reported. The device was later tested on the back table and demonstrated some movement but was left within the system.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037164 ↗MalfunctionJul 27, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037163 ↗MalfunctionJul 27, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50019936 ↗MalfunctionJul 27, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50019933 ↗MalfunctionJul 27, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015481 ↗MalfunctionJul 16, 2026Activation Failure
IT WAS REPORTED THAT DURING AN ELECTIVE PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY THE STENT AND ENCOUNTERED RESISTANCE. THE DELIVERY SYSTEM WAS REMOVED, AND A THIRD PARTY STENT DELIVERY SYSTEM WAS USED AND DEPLOYED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARD OR ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848634 ↗MalfunctionJul 16, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848632 ↗MalfunctionJul 16, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847273 ↗MalfunctionJul 15, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25833115 ↗MalfunctionJul 2, 2026Activation Failure
IT WAS REPORTED THAT DURING A PROCEDURE USING THE CGUARD PRIME STENT DELIVERY SYSTEM, THE PHYSICIAN EXPERIENCED EXTREME RESISTANCE DURING THE DEPLOYMENT SEQUENCE. THE STENT WOULD NOT UNSHEATHE, AND THE STENT WAS UNABLE TO DEPLOY. THE PROCEDURE WAS COMPLETED USING A COMPETITOR STENT, AND THERE WAS NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25700214 ↗MalfunctionJul 1, 2026Activation Failure
IT WAS REPORTED THAT DURING A PROCEDURE USING THE C GUARD PRIME STENT DELIVERY SYSTEM, THE PHYSICIAN EXPERIENCED EXTREME RESISTANCE DURING THE DEPLOYMENT SEQUENCE. THE STENT WOULD NOT UNSHEATHE, AND THE STENT WAS UNABLE TO DEPLOY. THE PROCEDURE WAS COMPLETED USING A COMPETITOR STENT , AND THERE WAS NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25686492 ↗MalfunctionFeb 10, 2026Activation Failure
DURING THE PROCEDURE, AN 8 FR BALLOON GUIDE CATHETER (0.087" INNER DIAMETER) WAS UTILIZED. THE LEFT INTERNAL CAROTID ARTERY WAS PREDILATED TWICE USING AN EMBOLIC PROTECTION DEVICE. THE PHYSICIAN WAS ABLE TO ADVANCE THE SYSTEM TO THE TARGET LESION AND CONFIRMED APPROPRIATE DEVICE POSITIONING WITHIN THE ANATOMY. THE SAFETY MECHANISM WAS DISENGAGED, AND THE DEPLOYMENT CONTROL WAS ADVANCED TO THE PRE-RELEASE POSITION AS INTENDED. DURING ATTEMPTED STENT DEPLOYMENT, RESISTANCE WAS ENCOUNTERED, AND THE DEVICE COULD NOT BE RELEASED. THE SYSTEM WAS SUBSEQUENTLY REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE STENT SYSTEM. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306179 ↗MalfunctionJan 9, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PHYSICIAN EXPEREINCED A NON-DEPLOYMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24027008 ↗MalfunctionJan 6, 2026Insufficient Device Problem Information
AFTER GETTING THE CGUARD INTO PLACE THE PHYSICIAN DEPLOYED AND HEARD THE CLICK HOWEVER HE COULD NOT EASILY CONTINUE DEPLOYING THE DEVICE. HE USED A COMPETITORS STENT AND COMPLETED THE PROCEDURE. THE PHYSICIAN MENTIONED IT WAS ALSO VERY DIFFICULT TO DEPLOY THE COMPETITORS STENT AND SAID IT WAS THE MOST DIFFICULT HE HAD EXPERIENCED. HE DID PRE-DILATE WITH A 5MM BALLOON PRIOR RO ATTEMPTING CGUARD. THERE WERE NO COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974564 ↗
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-2330-2026 · May 1, 2026 · Open, ClassifiedCGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
- Z-2327-2026 · May 1, 2026 · Open, ClassifiedCGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
- Z-2329-2026 · May 1, 2026 · Open, ClassifiedCGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
- 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
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
- ENROUTE Transcarotid Stent SR-0930-CSSilk Road Medical, Inc. · Stent, Carotid1 recall1 death21 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.
How reports and recalls are matched · Editorial policy · Report an error on this page