CGuard Prime Carotid Stent System CND0830Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07290120281691), received between Sep 25, 2025 and Aug 31, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (9 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.

Recalls naming this device

1. 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-2325-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531252 ↗
• MalfunctionAug 28, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50509759 ↗
• MalfunctionJul 28, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50048348 ↗
• MalfunctionJul 28, 2026Activation Failure

  It was reported that during an elective carotid artery stenting procedure, the operator experienced difficulty deploying the stent sliding the deployment lever. The procedure was completed using a third-party device (Protege) stent delivery system without any patient harm or adverse event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50048347 ↗
• MalfunctionJul 27, 2026Difficult or Delayed Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000121 ↗
• MalfunctionJul 27, 2026Difficult or Delayed Activation

  It was reported that during an elective carotid artery stenting procedure, the stent deivery system experienced difficulty unsheathing. The stent was able to be deployed successfully and the procedure was completed without any patient harm or adverse event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000120 ↗
• MalfunctionJul 16, 2026Break; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25849286 ↗
• MalfunctionJul 16, 2026Break; Activation Failure

  IT WAS REPORTED THAT DURING AN ELECTIVE TRANSFEMORAL CAROTID STENTING PROCEDURE, THE INITIAL STENT DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED THROUGH THE TORTUOUS ANATOMY. HOWEVER, DURING DEPLOYMENT, THE STENT FAILED TO RELEASE. ADDITIONAL FORCE WAS APPLIED IN AN ATTEMPT TO DEPLOY THE STENT, AT WHICH TIME THE SLIDER COMPONENT FRACTURED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT, AND INSPECTION CONFIRMED THAT THE STENT HAD NOT DEPLOYED. A SECOND STENT DELIVERY SYSTEM WAS INTRODUCED. DUE TO VESSEL TORTUOSITY, THE PHYSICIAN EXCHANGED THE EXISTING 6 FR COOK SHUTTLE GUIDING CATHETER FOR A NEW 6 FR COOK SHUTTLE GUIDING CATHETER. PRIOR TO DEPLOYMENT, THE PHYSICIAN RETRACTED THE GUIDING CATHETER TO HELP STRAIGHTEN THE VESSEL ANATOMY. SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT, REQUIRING INCREASED FORCE TO DEPLOY THE STENT. THE STENT WAS SUCCESSFULLY DEPLOYED IN THE INTENDED LOCATION. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED THROMBUS FORMATION, EMBOLIC COMPLICATIONS, OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25849282 ↗
• MalfunctionJul 2, 2026Break; Activation Failure

  IT WAS REPORTED THAT DURING AN ELECTIVE TRANSFEMORAL CAROTID STENTING PROCEDURE, THE INITIAL STENT DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED THROUGH THE TORTUOUS ANATOMY. HOWEVER, DURING DEPLOYMENT, THE STENT FAILED TO RELEASE. ADDITIONAL FORCE WAS APPLIED IN AN ATTEMPT TO DEPLOY THE STENT, AT WHICH TIME THE SLIDER COMPONENT FRACTURED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT, AND INSPECTION CONFIRMED THAT THE STENT HAD NOT DEPLOYED. A SECOND STENT DELIVERY SYSTEM WAS INTRODUCED. DUE TO VESSEL TORTUOSITY, THE PHYSICIAN EXCHANGED THE EXISTING 6 FR COOK SHUTTLE GUIDING CATHETER FOR A NEW 6 FR COOK SHUTTLE GUIDING CATHETER. PRIOR TO DEPLOYMENT, THE PHYSICIAN RETRACTED THE GUIDING CATHETER TO HELP STRAIGHTEN THE VESSEL ANATOMY. SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT, REQUIRING INCREASED FORCE TO DEPLOY THE STENT. THE STENT WAS SUCCESSFULLY DEPLOYED IN THE INTENDED LOCATION. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED THROMBUS FORMATION, EMBOLIC COMPLICATIONS, OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700212 ↗
• MalfunctionJul 2, 2026Activation Failure

  IT WAS REPORTED THAT DURING A TRANSFEMORAL PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE DEVICE THROUGH THE ILIAC ARTERY INTO THE AORTA. UPON REACHING THE TARGET LOCATION, INCREASED RESISTANCE WAS ENCOUNTERED DURING THE DEPLOYMENT SEQUENCE. THE DEVICE FAILED TO DEPLOY, AND THE DEPLOYMENT LEVER BECAME DAMAGED WHEN ADDITIONAL FORCE WAS APPLIED. THE PHYSICIAN SUBSEQUENTLY ATTEMPTED TO DEPLOY THE STENT ON THE BACK TABLE; HOWEVER, DEPLOYMENT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING A COMPETITOR STENT (ACCULINK), WHICH WAS SUCCESSFULLY DEPLOYED. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700209 ↗
• MalfunctionJul 1, 2026Break; Activation Failure

  IT WAS REPORTED THAT DURING AN ELECTIVE TRANSFEMORAL CAROTID STENTING PROCEDURE, THE INITIAL STENT DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED THROUGH THE TORTUOUS ANATOMY. HOWEVER, DURING DEPLOYMENT, THE STENT FAILED TO RELEASE. ADDITIONAL FORCE WAS APPLIED IN AN ATTEMPT TO DEPLOY THE STENT, AT WHICH TIME THE SLIDER COMPONENT FRACTURED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT, AND INSPECTION CONFIRMED THAT THE STENT HAD NOT DEPLOYED. A SECOND STENT DELIVERY SYSTEM WAS INTRODUCED. DUE TO VESSEL TORTUOSITY, THE PHYSICIAN EXCHANGED THE EXISTING 6 FR COOK SHUTTLE GUIDING CATHETER FOR A NEW 6 FR COOK SHUTTLE GUIDING CATHETER. PRIOR TO DEPLOYMENT, THE PHYSICIAN RETRACTED THE GUIDING CATHETER TO HELP STRAIGHTEN THE VESSEL ANATOMY. SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT, REQUIRING INCREASED FORCE TO DEPLOY THE STENT. THE STENT WAS SUCCESSFULLY DEPLOYED IN THE INTENDED LOCATION. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED THROMBUS FORMATION, EMBOLIC COMPLICATIONS, OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686480 ↗
• MalfunctionJul 1, 2026Activation Failure

  IT WAS REPORTED THAT DURING A TRANSFEMORAL PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE DEVICE THROUGH THE ILIAC ARTERY INTO THE AORTA. UPON REACHING THE TARGET LOCATION, INCREASED RESISTANCE WAS ENCOUNTERED DURING THE DEPLOYMENT SEQUENCE. THE DEVICE FAILED TO DEPLOY, AND THE DEPLOYMENT LEVER BECAME DAMAGED WHEN ADDITIONAL FORCE WAS APPLIED. THE PHYSICIAN SUBSEQUENTLY ATTEMPTED TO DEPLOY THE STENT ON THE BACK TABLE; HOWEVER, DEPLOYMENT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING A COMPETITOR STENT (ACCULINK), WHICH WAS SUCCESSFULLY DEPLOYED. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686468 ↗
• MalfunctionJan 6, 2026Insufficient Device Problem Information

  THE CATHETER JUST SOUTH OF THE CONSTRAINED 8X30 STENT WAS VISIBLY KINKED ANGIOGRAPHICALLY. THE KINK WAS CONFIRMED ON THE BACK TABLE. IT WASN'T SIGNIFICANT, BUT ENOUGH THAT IT DIDN'T ALLOW THE PHYSICIAN TO ADVANCE THE SYSTEM CONFIDENTLY WITHOUT RISKING LOSING ACCESS IN THE CCA. HE DEPLOYED THE STENT SMOOTHLY THROUGH THE KINKED CATHETER ON THE BACK TABLE AND COMPLETED THE PROCEDURE WITH A COMPETITOR'S DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975895 ↗
• MalfunctionSep 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING THE PROCESS OF INSERTING THE WIRE INTO THE DELIVERY SYSTEM, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS BENT, AND SEPARATION WAS OBSERVED. IT WAS DECIDED NOT TO USE THE PRODUCT. ANOTHER STENT DELIVERY SYSTEM FROM INSPIRE MD WAS USED TO COMPLETE THE SURGERY. NOT PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23170520 ↗
• MalfunctionSep 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS DELIVERED SUCCESSFULLY TO THE LESION; HOWEVER, THE DEVICE WOULD NOT DEPLOY DUE TO SIGNIFICANT RESISTANCE OF THE BLUE DEPLOYMENT SLIDER. THE BLUE DEPLOYMENT WOULD NOT PULL BACK. THE STENT WAS REMOVED SUCCESSFULLY AND AN ALTERNATIVE STENT FROM A DIFFERENT COMPANY WAS SELECTED, DELIVERED AND DEPLOYED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144653 ↗

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-2326-2026 · May 1, 2026 · Open, Classified
  Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
• Z-2330-2026 · May 1, 2026 · Open, Classified
  CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
• Z-2327-2026 · May 1, 2026 · Open, Classified
  CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
• Z-2329-2026 · May 1, 2026 · Open, Classified
  CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
• Z-2328-2026 · May 1, 2026 · Open, Classified
  Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940