Cordis Corporation Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
Brand
Cordis Corporation
Lot Codes / Batch Numbers
Lot no. X1004212
Products Sold
Lot no. X1004212
Cordis Corporation is recalling Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents. due to Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.
Recommended Action
Per FDA guidance
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.
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