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U.S. Department of Health and Human Services

Class 2 Device Recall Cypher sterile stent

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  Class 2 Device Recall Cypher sterile stent see related information
Date Initiated by Firm January 12, 2005
Date Posted January 26, 2005
Recall Status1 Terminated 3 on February 09, 2005
Recall Number Z-0437-05
Recall Event ID 30903
PMA Number P020026 
Product Classification Coronary Drug-Eluting Stent - Product Code NIQ
Product Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
Code Information Lot no. X1004212
Recalling Firm/
Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
Manufacturer Reason
for Recall
Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.
FDA Determined
Cause 2
Action A withdrawal letter is in the process of being hand-delivered to accounts that received this lot, by a Cordis sales representative. Any remaining units from this lot are being removed, and returned to Cordis. The returned units will be scrapped. An Acknowledgement Form is being signed indicating that the account was informed, and documenting whether there is any remaining product from this lot. The withdrawal action was initiated January 12, 2005.
Quantity in Commerce 300
Distribution Distributed throughout 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.
PMA Database PMAs with Product Code = NIQ and Original Applicant = CORDIS CORP.