Z-2052-2009

Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn...

Name: Z-2052-2009 Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn...
Creator: Boston Scientific Corporation
Published: 2009-05-08
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-05-08 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific... on 2009-05-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2052-2009
Status: Terminated
Initiated: 2009-05-08
Posted: 2009-09-09
Terminated: 2009-10-21
Recalling firm: Boston Scientific Corporation
Product: Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
Product code: NJE Intracranial Neurovascular Stent
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm issued an Urgent Product Field Action Notice to all listed customers, along with a reply verification form, requesting the return of affected products.
Quantity in commerce: 8 units
Distribution: International Distribution Only -- Countries of Germany, Great Britain, France, Ireland, and Italy.
Product codes and lots: Batch numbers 8048028 and 8048029.

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)