• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Neuroform 3 Microdelivery Stent System

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Neuroform 3 Microdelivery Stent System see related information
Date Initiated by Firm May 08, 2009
Date Posted September 09, 2009
Recall Status1 Terminated 3 on October 21, 2009
Recall Number Z-2052-2009
Recall Event ID 52668
Product Classification Intracranial Neurovascular Stent - Product Code NJE
Product Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
Code Information Batch numbers 8048028 and 8048029.
Recalling Firm/
Boston Scientific Corporation
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.