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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Batch numbers 8048028 and 8048029.
Products Sold
Batch numbers 8048028 and 8048029.
Boston Scientific Corporation is recalling Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026