FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
- Recall number
- Z-2052-2009
- 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.
- Status
- Terminated
- Initiated
- 2009-05-08
- Posted
- 2009-09-09
- Terminated
- 2009-10-21
- Reason
- 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
- 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
- 8 units
- Distribution
- International Distribution Only -- Countries of Germany, Great Britain, France, Ireland, and Italy.
- Lot, serial or model codes
- Batch numbers 8048028 and 8048029.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJE
- Firm FEI
- 2939204
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28