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Intracranial Neurovascular Stent
FDA product code NJE · Class f · Unknown
179
Registered devices
7,840
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
LVIS Jr. — Microvention, Inc.LVIS — Microvention, Inc.Neuroform Atlas — Stryker CorporationNeuroform Atlas — Stryker CorporationGateway® — BOSTON SCIENTIFIC CORPORATIONGateway® — BOSTON SCIENTIFIC CORPORATIONWingspan — Stryker CorporationPulseRider Aneurysm Neck Reconstruction Device — Medos International SàrlCERENOVUS ENTERPRISE — Medos International SàrlCERENOVUS ENTERPRISE — Medos International SàrlLVIS Jr. — Microvention, Inc.PulseRider Aneurysm Neck Reconstruction Device — Medos International SàrlWingspan — Stryker CorporationGateway® — BOSTON SCIENTIFIC CORPORATIONCERENOVUS ENTERPRISE — Medos International SàrlLVIS — Microvention, Inc.CERENOVUS ENTERPRISE — Medos International SàrlLVIS Junior — Microvention, Inc.LVIS — Microvention, Inc.Neuroform Atlas — Stryker CorporationLVIS Junior — Microvention, Inc.Wingspan — Stryker CorporationLVIS — Microvention, Inc.LVIS — Microvention, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-05 | Stryker Neurovascular | Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported |
| 2014-10-22 | Stryker Neurovascular | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. |
| 2013-06-24 | Stryker Neurovascular | The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same |
| 2011-03-21 | Codman & Shurtleff, Inc. | Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product |
| 2010-08-25 | Boston Scientific Corporation | Products may not meet radial force specifications. |
| 2010-03-01 | Boston Scientific Corporation | The product may contain manufacturing aids (mandrels) which should not be present in the final product. If the mandrel remains in place, the catheter cannot be |
| 2009-05-08 | Boston Scientific Corporation | Mislabeling-- Product was placed in a carton, which has printed on it the name of another product. A correct product label was placed on the carton. |
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