Neuroguard IEP Carotid Stent System Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Contego Medical, Inc. is recalling 5,069 units of the Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System due to a potential failure of the integrated embolic protection filter to open.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Contego Medical, Inc. initiated a voluntary recall of the Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System) because the integrated filter may fail to open following sheath retraction due to a wire-to-filter-bond issue. If this occurs during a procedure, it may result in loss of intended integrated embolic protection.
Which Products Are Affected
The recall affects 5,069 units distributed nationwide in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, and CA. Affected models include:
- REF NG-0630-140-2 (UDI-DI 00851616007583)
- REF NG-0640-140-2 (UDI-DI 00851616007590)
- REF NG-0730-140-2 (UDI-DI 00851616007606)
- REF NG-0740-140-2 (UDI-DI 00851616007613)
- REF NG-NV-6-30 (UDI-DI 00851616007644)
- REF NG-NV-6-40 (UDI-DI 00851616007651)
- REF NG-NV-7-30 (UDI-DI 00851616007637)
- REF NG-NV-7-40 (UDI-DI 00851616007620)
Specific lot numbers are listed in FDA recall Z-2911-2026. The recall is classified as Class II.
What You Should Do
The recalling firm notified customers via letter. Healthcare providers and facilities should follow the instructions provided in the notification for affected devices.
Why This Matters
This Class II recall involves a device distributed across multiple U.S. states where a filter malfunction could compromise embolic protection during carotid procedures.
Source
FDA recall number Z-2911-2026, initiated June 29, 2026, by Contego Medical, Inc., Raleigh, NC.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,522 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.