Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • 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 see related information
Date Initiated by Firm March 17, 2003
Date Posted April 22, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall Number Z-0778-03
Recall Event ID 25947
Product Classification Stent, Coronary - Product Code MAF
Product N/A
Code Information N/A
Recalling Firm/
Manufacturer		 Boston Scientific Scimed
One Scimed Place
Maple Grove MN 55311-1566
Manufacturer Reason
for Recall		 A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
FDA Determined
Cause 2		 Other
Action Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them.
Distribution Nationwide in the United States
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.
-
-