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URGENT RECALL NOTICE - Immediate Action Required TAXUSTM Express2TM Paclitaxel-Eluting Coronary Stent Systems and Express2TM Coronary Stent Systems

Jul 20, 2004 | www.hc-sc.gc.ca

Dear Risk Manager,

On July 2, 2004, Boston Scientific initiated a voluntary recall of two lots of TAXUSTM Express2TM Paclitaxel-Eluting Coronary Stent Systems after determining that units from these lots may have an increased likelihood of focal neckdown (narrowing) of the balloon deflation lumen, which could result in an increased possibility of a "no deflation" condition.

Upon additional analysis and investigation of "no deflation" complaints, Boston Scientific is extending the scope of this recall to include certain additional lots of the TAXUSTM Express2TM Paclitaxel-Eluting Coronary Stent Systems, as well as specific lots of the Express2TM Coronary Stent Systems. Units from these lots may also have an increased likelihood of focal neckdown of the balloon deflation lumen. This voluntary recall does not impact the safety of stents which have been implanted in patients. Patients with the Express2TM or TAXUSTM Express2TM stents should be reassured that this recall does not implicate the stent itself and their ongoing care is unchanged.

We are sending you this recall notification because our records indicate that your institution received one or more units of TAXUSTM Express2TM Paclitaxel- Eluting Coronary Stent Systems and/or Express2TM Coronary Stent Systems.

A "no deflation" complaint is defined as a reported failure of the delivery balloon to deflate within one minute. "No deflation" can cause significant patient complications including coronary artery bypass graft (CABG) surgery and death. Corrective actions associated with the root cause of the "no deflate" condition have been identified and were implemented after the manufacturing dates of the lots subject to this recall.

The information set forth on Attachment A to this letter describes the lots of TAXUSTM Express2TM Paclitaxel-Eluting Coronary Stent Systems that are subject to this recall. The information set forth on Attachment B to this letter describes the lots of Express2TM Coronary Stent Systems that are subject to this recall. Coronary Stent Systems having lot numbers that are not described on Attachments A or B are not subject to this recall.

PLEASE IMMEDIATELY DISCONTINUE USE OF AND SEGREGATE ALL UNITS FROM THESE RECALLED LOTS.

Please carefully review and follow the enclosed steps for Voluntary Recall and complete and return the enclosed Tracking/Verification Form.

Your local Boston Scientific sales representative can answer questions that you may have regarding this voluntary recall. Any TAXUSTM Express2TM Paclitaxel-Eluting Coronary Stent Systems returned will be exchanged, or at your request a credit will be issued. Any Express2TM Coronary Stent Systems returned will be exchanged, or at your request a credit will be issued.


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