Carotid stent systems recalled because integrated filter may not fully open
Contego Medical is recalling 568 Neuroguard IEP carotid stent systems because the integrated filter may not open, or may not fully open, during sheath retraction and filter knob operation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: an embolic protection filter that may not deploy fully is a clinical risk during carotid stenting, and no injuries are reported.
Plain-English summary
The Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection, REF NG-0740-140-2, NG-NV-7-40, NG-0640-140-2 and NG-NV-6-40, is being recalled.
The system's integrated filter 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.
The recall covers 568 units, distributed in Florida, Colorado, California, Illinois, North Carolina, Kentucky, Texas, Pennsylvania, Delaware, New Jersey, Indiana, New York, Ohio, Louisiana, Oklahoma, South Carolina and Connecticut. The FDA has classified the action as Class II.
The enforcement record describes the filter deployment issue and reports no injuries. Facilities should follow Contego Medical's instructions for affected lots.
The recalled product
- Product
- Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40
- Manufacturer
- Contego Medical LLC
- Category
- Medical Device — Vascular stent
- Affected units
- 568
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- REF/UDI-DI/Lot(Expiration): NG-0740-140-2/00851616007613/Z2460707D(Z2460707D)
- Z2460733A(03/05/2027)
- Z2460766A(04/07/2027)
- Z2460774B(04/17/2027)
- Z2460780A(04/18/2027)
- NG-0640-140-2/00851616007590/Z2460746C(03/20/2027)
- Z2460774A(04/18/2027)
- NG-NV-7-40/00851616007620/Z2460776D(04/14/2027)
- NG-NV-6-40/00851616007651/Z2460776B(04/16/2027)
Distribution
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