Neuroguard IEP System recallZ-2911-2026 · Contego Medical, Inc · initiated Jun 29, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Contego Medical, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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 [email protected] Questions can be directed to the firm at [email protected] and 919-459-7250 Extension 4.
Recall details
- Recall number
- Z-2911-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 29, 2026
- Posted by the FDA
- Aug 6, 2026
- Recalling firm
- Contego Medical, Inc
- Quantity
- 5069
- Product code
- NIM
- FDA submissions
- P240009
- Distribution
- US Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
REF/UDI-DI/Lot: NG-0630-140-2/00851616007583/Z2460578D,Z2460740B, Z2460872C, Z2460909F, Z2460948D, Z2460957Q; NG-0640-140-2/00851616007590/Z2460578E, Z2460647S, Z2460706A, Z2460746C, Z2460774A, Z2460865C, Z2460872B, Z2460901B, Z2460909D, Z2460909K, Z2460945H, Z2460948I, Z2460963N; NG-0730-140-2/00851616007606/Z2460578F, Z2460662A, Z2460740A , Z2460774F, Z2460850A, Z2460900B, Z2460945F, Z2460957R; NG-0740-140-2/00851616007613/Z2460578G, Z2460635C, Z2460656A, Z2460707D, Z2460733A, Z2460766A, Z2460774B, Z2460780A , Z2460865A, Z2460871A, Z2460872D, Z2460900D, Z2460909B, Z2460909I, Z2460948F, Z2460963T; NG-NV-6-30/00851616007644/Z2460776A, Z2460893A, Z2460909G, Z2460948E; NG-NV-6-40/00851616007651/Z2460776B, Z2460865D, Z2460865E, Z2460901C, Z2460909E, Z2460909J, Z2460957P, Z2460963K, Z2460963P; NG-NV-7-30/00851616007637/Z2460776C, Z2460789H, Z2460850B, Z2460900C, Z2460916A, Z2460948H, Z2460998A; NG-NV-7-40/00851616007620/Z2460776D, Z2460878A, Z2460872A, Z2460872E, Z2460901A, Z2460909C, Z2460909H, Z2460945G, Z2460948G, Z2460966B, Z2460963J;
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- Neuroguard IEP® System NG-0740-140-2Contego Medical, Inc. · Stent, Carotid2 recalls32 reports
- Neuroguard IEP® System NG-NV-6-40Contego Medical, Inc. · Stent, Carotid2 recalls9 reports
- Neuroguard IEP® System NG-NV-7-40Contego Medical, Inc. · Stent, Carotid2 recalls8 reports
- Neuroguard IEP® System NG-0640-140-2Contego Medical, Inc. · Stent, Carotid2 recalls7 reports
- Neuroguard IEP® System NG-0730-140-2Contego Medical, Inc. · Stent, Carotid1 recall5 reports
- Neuroguard IEP® System NG-0630-140-2Contego Medical, Inc. · Stent, Carotid1 recall3 reports
- Neuroguard IEP® System NG-NV-6-30Contego Medical, Inc. · Stent, Carotid1 recall2 reports
- Neuroguard IEP® System NG-NV-7-30Contego Medical, Inc. · Stent, Carotid1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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