Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP

FDA device recall Z-2911-2026 · posted 2026-08-06 · Open, Classified

Recall details

Recalling firm

Contego Medical, Inc

Reason for recall

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.

Action taken

On 6/29/2026, recall notices started being delivered to healthcare professionals and risk managers by Medtronic sales representatives who informed of the following: 1) Sales representatives will visit, conduct inventory counts, quarantine, and remove unused affected devices. 2) If replacements are desired, they can be provided. 3) Complete and return the acknowledgment form via email to recall@contegomedical.com Questions can be directed to the firm at recall@contegomedical.com and 919-459-7250 Extension 4.

Root cause

Process control

Status

Open, Classified

Product code

NIM

Quantity affected

5069

Distribution

US Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA.

Date initiated

2026-06-29

Date posted

2026-08-06

Location

Raleigh, NC