Contego Medical LLC recalls Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Em…

Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.

On 9/4/2025, communication and training to the field representatives started with in person letter distribution following immediately after. Customers were asked to do the following: Action Required 1) Inventory Check: Medtronic and Contego sales representatives will visit your facility to conduct an inventory count of devices from the affected lots. 2) Quarantine Affected Devices: Any identified devices will be removed from use and quarantined by the Medtronic or Contego team. 3) Return: Medtronic and Contego will remove affected devices. If replacements are desired, they can be provided during the same visit. 4) Confirmation: Sign and return the enclosed acknowledgment form to confirm receipt of this advisory and the completion of actions performed by Medtronic or Contego. 5) Please email the completed form to Contego Medical recall@contegomedical.com as soon as possible and retain a copy of the form to provide to the representative at the time of their visit. If you have questions, contact the firm's Recall Support Team at recall@contegomedical.com or call 919-459-7250 Extension 4.

• FDA enforcement recordOfficial FDA database entry for Z-0131-2026
• FDA device classification · NIMOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Contego Medical LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.