Neuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
Contego Medical, Inc is recalling Neuroguard IEP Carotid Stent and Post-Dilation Balloon Systems due to a potential filter failure issue.
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: The product is a high-risk medical device where a failure to provide intended embolic protection poses a significant risk of harm, though no injuries have been reported in the source text.
Plain-English summary
Contego Medical, Inc is recalling the Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System).
The device contains an integrated filter that may fail to open after the sheath is retracted due to a wire-to-filter-bond issue. If the filter fails to open during a medical procedure, the device may not provide the intended embolic protection.
This 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.
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-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
- Manufacturer
- Contego Medical, Inc
- Affected units
- 5,069
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 (20)
- 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
Distribution
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