Z-0437-05

Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents

Name: Z-0437-05 Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents
Creator: Cordis Corporation
Published: 2005-01-12
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2005-01-12 / Terminated

FDA source

Cordis Corporation began a recall of Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents on 2005-01-12. The reason FDA records is "Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0437-05
Status: Terminated
Initiated: 2005-01-12
Posted: 2005-01-26
Terminated: 2005-02-09
Recalling firm: Cordis US Corp.
Product: Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
Product code: NIQ Coronary Drug-Eluting Stent
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 root cause: Other
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.
Product codes and lots: Lot no. X1004212

Product code NIQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)