Intracranial Neurovascular Stent
FDA adverse event reports and recall history for intracranial neurovascular stent (product code NJE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 7,770
- Deaths
- 536
- Injuries
- 2,901
- Malfunctions
- 4,314
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2014-12-16TerminatedProcess control
Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
- 2013-07-25TerminatedPackaging process control
Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.
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 lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent).
- 2011-06-29TerminatedLabeling design
CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812
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 is 28mm in length.
- 2010-12-16TerminatedProcess control
Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA Indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with less than or equal to 50% stenosis that are accessible to the system.
Products may not meet radial force specifications.
- 2010-11-26TerminatedProcess control
Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific Corporation, Fremont, CA
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 loaded over the required guidewire, so cannot be used.
- 2009-09-09TerminatedEmployee error
Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
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.
- TerminatedUse error
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
Monitor intracranial neurovascular stent automatically
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