—#36787

Product

Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.

FDA product code: NIQ — Coronary Drug-Eluting Stent
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P020026
Affected lot / code info: Lot no. X1004212

Why it was recalled

Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Distributed throughout the United States.

Timeline

Recall initiated: 2005-01-12
Posted by FDA: 2005-01-26
Terminated: 2005-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36787. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.