Contego Medical, Inc: Stent, Carotid
Consumer Summary Contego Medical is recalling certain Neuroguard IEP carotid stents because a manufacturing defect in the integrated filter's wire-to-filter bond may prevent the filter from opening properly during use. If the filter fails to open during a procedure, patients may lose the intended protection against blood clots and debris. The affected stents were distributed nationwide to medical facilities in multiple states.
- Recalling firm
- Contego Medical, Inc
- Product
- Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
- Reason
- Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b072d2cb-0f7a-407e-9830-349f7b5d2bc7