CGuard Prime Carotid Stent System CND1040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07290120281783), received between Nov 4, 2025 and Aug 17, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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-2330-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Difficult or Delayed Activation

  It was reported that during an elective transfemoral carotid artery stenting procedure, the operator applied "extreme pressure" of th CGuard Prime stent delivery system to deploy the stent. The stent was able to be deployed successfully, however the stent was deployed covering a portion of the lesion. A secondary InspireMD stent was used to cover the lesion and the procedure was completed without any patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50276333 ↗
• InjuryAug 5, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148448 ↗
• InjuryAug 5, 2026Activation Failure

  It was reported during a trans ulnar access case, the physician experienced a non-deployment using the CGuard Prime Carotid Stent System 135cm. The physician attempted to use a secondary CGuard Prime Carotid Stent System 135cm using the trans femoral approach, however the issue persisted. A competitor stent was used to complete the procedure successfully with no reported patient harm. The system was able to be deployed outside of the patients body.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148447 ↗
• MalfunctionDec 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE FOLLOWING: PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE. PATIENT IS DOING WELL; HOWEVER, THE NOSE OF THE STENT POST DEPLOYMENT WA GETTING STUCK PRIOR RO POST DILATION. HE USED A 3.5 BALLOON FREE IN A MODERATELY CALCIFIED LESION, FOLLOWED WITH A 5.5 BALLOON. DURING THE DEPLOYMENT PROCESS THE STENT DID JUMP BUT DID NOT MIS THE (STENOSIS) LESION, HOWEVER IT DID NOT DEPLOY AT THE DESIRED LOCATION AND HAD TO EXPAND THE STENT. THE PHYSICIAN USED A COMPETITOR STENT TO COVER THE PROXIMAL COMMON CAROTID. THE PHYSICIAN DID NOT EXPERIENCE RESISTANCE. THE NOSE CONE IS BULKY PER PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23805266 ↗
• MalfunctionDec 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE FOLLOWING: PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE. PATIENT IS DOING WELL; HOWEVER, THE NOSE OF THE STENT POST DEPLOYMENT WA GETTING STUCK PRIOR RO POST DILATION. HE USED A 3.5 BALLOON FREE IN A MODERATELY CALCIFIED LESION, FOLLOWED WITH A 5.5 BALLOON. DURING THE DEPLOYMENT PROCESS THE STENT DID JUMP BUT DID NOT MIS THE (STENOSIS) LESION; HOWEVER, IT DID NOT DEPLOY AT THE DESIRED LOCATION AND HAD TO EXPAND THE STENT. THE PHYSICIAN USED A COMPETITOR STENT TO COVER THE PROXIMAL COMMON CAROTID. THE PHYSICIAN DID NOT EXPERIENCE RESISTANCE. THE NOSE CONE IS BULKY PER PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803692 ↗
• MalfunctionNov 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN INTERVENTION OF A PATIENT EXPERIENCING CLOTS, DISSECTION AND CALCIFICATION IN THE CAROTID, THE PHYSICIAN DECIDED TO USE A CND1040. THE PHYSICIAN WAS ABLE TO ADVANCE INTO THE LESION, BUT DURING DEPLOYMENT, RESISTANCE WAS EXPERIENCED, AND THE STENT DID NOT DEPLOY. THE PHYSICIAN DECIDED NOT TO CONTINUE APPLYING FORCE INTO THE DELIVERY SYSTEM AND PROCEEDED TO REMOVE THE CATHETER/STENT. THE PHYSICIAN FINISHED THE PROCEDURE WITH A COMPETITOR STENT. NO HARM TO THE PATIENT REPORTED. AFTER THE PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY THE STENT IN A FLAT TABLE. STENT DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466394 ↗

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-2329-2026 · May 1, 2026 · Open, Classified
  CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
• Z-2327-2026 · May 1, 2026 · Open, Classified
  CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
• Z-2325-2026 · May 1, 2026 · Open, Classified
  Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
• Z-2326-2026 · May 1, 2026 · Open, Classified
  Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
• Z-2328-2026 · May 1, 2026 · Open, Classified
  Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940