DeviceSignal · Recall classified
Contego Medical, Inc
FDA classified a device recall on 2026-08-06 · Class II · Z-2911-2026
EventRecall classified
Effective2026-08-06
ClassificationClass II
On 2026-08-06 the FDA classified a device recall from Contego Medical, Inc as Class II. Product: Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated…. Recall Z-2911-2026. The firm initiated it on 2026-06-29. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2911-2026
- Classification
- Class II
- Classified on
- 2026-08-06
- Initiated on
- 2026-06-29
- Firm
- Contego Medical, Inc
- 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.
- 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
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2911-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
900639fcb8018c937ee33003025f2711df05edf4d0a9892350b1b9e8166c9ccd- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)