Date Initiated by Firm |
July 16, 2003 |
Date Posted |
August 12, 2003 |
Recall Status1 |
Terminated 3 on December 28, 2006 |
Recall Number |
Z-1123-03 |
Recall Event ID |
26881 |
PMA Number |
P020009 |
Product Classification |
Stent, Coronary - Product Code MAF
|
Product |
Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235 |
Code Information |
Lot 5570485 |
Recalling Firm/ Manufacturer |
Boston Scientific Scimed One Scimed Place Maple Grove MN 55311-1566
|
For Additional Information Contact |
Patrick Burt 763-494-1192
|
Manufacturer Reason for Recall |
There is an Increased potential for broken struts of the stents.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were sent a recall letter dated July 16, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them. |
Quantity in Commerce |
17 stent systems |
Distribution |
The products were shipped to consignees located nationwide in the United States. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
|
PMA Database |
PMAs with Product Code = MAF and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
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