Z-1808-2013Class II

Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020...

Name: Z-1808-2013 Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020...
Creator: Stryker Neurovascular
Published: 2013-06-24
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-06-24 / Terminated / root cause: packaging

FDA source

Stryker Neurovascular began a recall of 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... on 2013-06-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1808-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-24
Posted: 2013-07-25
Terminated: 2013-09-30
Recalling firm: Stryker Corp.
Product: 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.
Product code: NJE Intracranial Neurovascular Stent
Reason for recall: 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).
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Stryker Neurovascular sent an Urgent Field Safety Notice on June 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their internal inventory and quarantine all subject devices pending return to Stryker. Circulate the Field Safety Notice internally to all interested/affected parties. Maintain awareness of this notice internally until all requred actions have been completed within their facility. Inform Stryker if any of the subject devices were distributed to other organization. Complete the attached customer response form and return to their Stryker Representataive. For questions regarding this recall call 510-413-2500.
Quantity in commerce: 23 units
Distribution: International Distribution including Austria, China, and Germany.
Product codes and lots: Code: M003450200, Lot 15391019, Expiration Date: 2015-07

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1808-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1808-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-25

Product code NJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)