CGuard Prime Carotid Stent System CND0840Recalls & reported problems
Inspire M.D Ltd · CGuard Prime Carotid Stent System 135cm, 8mmx40mm · 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
The InspireMD CGuard Prime is a carotid stent used to open narrowed arteries in the neck. Most of the 43 reports describe the stent failing to activate or deploying with high resistance during the procedure, plus a few cases of broken or separating parts; 7 reports involve injuries and 1 death. One open recall, started in May 2026, says the delivery system can meet resistance during deployment and fail to release the stent. Reports rose sharply, from 2 in the prior 12 months to 41.
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
- 41
- Deaths reported
- 1
- Injuries reported
- 7
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 07290120281707), received between Sep 25, 2025 and Sep 1, 2026 — classified as 1 death, 7 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (22 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-2326-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Activation Failure22
- Insufficient Device Problem Information8
- Difficult or Delayed Activation7
- Break3
- Adverse Event Without Identified Device or Use Problem2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Stroke/CVA2
- Arteriosclerosis/ Atherosclerosis1
- Thrombosis/Thrombus1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543807 ↗MalfunctionAug 28, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50501457 ↗MalfunctionAug 28, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50500247 ↗MalfunctionAug 5, 2026Break; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50148450 ↗MalfunctionAug 5, 2026Break; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50148449 ↗MalfunctionAug 5, 2026Break; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50148446 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Transcarotid Artery Revascularization (TCAR) procedure with implantation of a CGuard Prime Carotid Stent 135 and subsequently experienced a neurological event. The physician confirmed a stroke through physical neurological examination findings, computed tomography angiography (CTA), and magnetic resonance imaging (MRI) performed the day following the procedure. Additional information was received on January 8, 2026 indicating that according to the physician, the patient's neurological symptoms returned to baseline during the subsequent week.
Patient problems: Stroke/CVA
MAUDE report 50124750 ↗MalfunctionJul 27, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035527 ↗MalfunctionJul 27, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50034585 ↗MalfunctionJul 27, 2026Difficult or Delayed Activation
It was reported that during an transfemoral case in the left internal carotid artery, the physician had significant trouble retracting the blue slider. The stent deivery system experienced difficulty deploying the stent. The stent deployed successfully, and the procedure was completed without any patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50000122 ↗MalfunctionJul 21, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25892015 ↗MalfunctionJul 21, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT DURING AN ELECTIVE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING DIFFIULTY DEPLOYING THE STENT. THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT SUCCESSFULLY, AND THERE WAS NO REPORTED PATIENT INJURY OR ADVERSE CLINICAL OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25892000 ↗MalfunctionJul 21, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25890879 ↗MalfunctionJul 17, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25856787 ↗MalfunctionJul 17, 2026Activation Failure
IT WAS REPORTED THAT DURING AN ELECTIVE TRANSFEMORAL PROCEDURE, THE CGUARD STENT DEPLOYMENT SYSTEM WAS UNABLE TO DEPLOY. THE PHYSICIAN ATTEMPTED A SECONDARY STENT WHICH DEPLOYED SUCCESSFULLY. THERE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTTED PATIENT INJURY OR ADVERSE CLINICAL OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25856781 ↗MalfunctionJul 17, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25856779 ↗MalfunctionJul 17, 2026Activation Failure
IT WAS REPORTED THAT DURING AN ELECTIVE TRANSFEMORAL STENT PROCEDURE, THE CGUARD PRIME STENT WOULD NOT DEPLOY. A SECONDARY STENT AND WAS ATTEMPTED AND THE STENT WOULD NOT DEPLOY. A COMPETITOR STENT (BOSTON SCIENTIFIC WALLSTENT) WAS DEPLOYED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25856778 ↗MalfunctionJul 17, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25856776 ↗MalfunctionJul 16, 2026Activation Failure
IT WAS REPORTED THAT DURING AN ELECTIVE TRANSFEMORAL PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE DEPLOYING THE STENT. THE PHYSICIAN ATTEMPTED A SECONDARY STENT AND RESISTANCE WAS ALSO FELT. A COMPETITOR STENT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847288 ↗MalfunctionJul 16, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847282 ↗MalfunctionJul 16, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847280 ↗MalfunctionJul 16, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847275 ↗MalfunctionJul 16, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847274 ↗MalfunctionJul 16, 2026Activation Failure
IT WAS REPORTED THAT DURING AN ELECTIVE TRANSFEMORAL PROCEDURE, DURING THE DEPLOYMENT SEQUENCE, THE CGUARD PRIME STENT WAS ADVANCED TO THE TARGET LOCATION; HOWEVER, THE STENT WAS UNABLE TO BE DEPLOYED. A SECOND STENT SYSTEM WAS THEN INTRODUCED AND DEPLOYED SUCCESSFULLY. A 6×30 STERLING BALLOON WAS USED FOR POST DILATATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847272 ↗MalfunctionJul 2, 2026Activation Failure
IT WAS REPORTED THAT DURING AN ELECTIVE TRANSFEMORAL CAROTID INTERVENTION PERFORMED IN A PATIENT WITH A TYPE II TORTUOUS AORTIC ARCH AND A SEVERELY CALCIFIED ~95% STENOTIC LESION. UPON ADVANCING OF THE FIRST STENT DELIVERY SYSTEM, THE SYSTEM FAILED TO DEPLOY. THE DELIVERY SYSTEM WAS REMOVED, AND DURING HANDLING OUTSIDE THE PATIENT, THE HANDLE BROKE; SUBSEQUENT MANIPULATION OF THE NOSE CONE RESULTED IN STENT DEPLOYMENT OUTSIDE THE PATIENT. A SECOND STENT DELIVERY SYSTEM WAS INTRODUCED BUT EXHIBITED THE SAME FAILURE TO DEPLOY AND WAS REMOVED WITHOUT DEPLOYMENT. A THIRD STENT DELIVERY SYSTEM WAS THEN ADVANCED AND DEPLOYED SUCCESSFULLY, COMPLETING THE PROCEDURE. THE PHYSICIAN REPORTED THE DEPLOYMENT LEVER INITIALLY FELT NORMAL BUT BECAME STUCK DURING ATTEMPTED DEPLOYMENT. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25700213 ↗
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-2330-2026 · May 1, 2026 · Open, ClassifiedCGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
- Z-2329-2026 · May 1, 2026 · Open, ClassifiedCGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
- Z-2328-2026 · May 1, 2026 · Open, ClassifiedBrand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
- 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 CND0940Inspire M.D Ltd · Stent, Carotid1 recall31 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.
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