Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA
- Recall Initiated
- May 1, 2007
- Posted
- August 9, 2007
- Terminated
- March 2, 2008
- Recall Number
- Z-1161-2007
- Quantity
- 2487
- Firm Location
- Scientific Place Natick, MA
Reason for Recall
Boston Scientific NexStent Carotid Stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent.
Distribution
Worldwide, including USA, France, Italy, Germany, Belgium, Cyprus, Austria, Spain, Finland, Netherlands, Luxembourg, Romania , Czech Republic, Poland, Israel, Hungary, New Zealand, and Switzerland.
Lot / Code Info
Lots distributed in US: C64701, C64702, C64703, C64704, C64705, C64706, C64801, C64802, C64803, C64804, C70101, C70102, C70103, C70104, C70105, C70201, C70202, C70203, C70204, C70205, C70206, C70207, C70208, C70209, C70210, C70211, C70212, C70213, C70214, C70215, C70216, C70217, C70218, C70219, C70220, C70221, C70222, C70223, C70224, C70225, C70226, C70227, C70228, C70229, C70230, C70231, C70232, C70233, C70301. Lots distributed OUS: C51301, C52501, C52502, C52703, C61401, C61402, C61403, C61501, C61502, C61503, C61601, C61602, C61603, C61604, C61605, C61701, C61702, C61801, C61802, C61803, C61804, C61805, C61901, C61902, C62001, C62002, C62003, C62004, C63701, C63901, C64001, C64002, C64101, C64102, C64501, C65101, C65102.
Root Cause
Other
Action Taken
On May 1, 2007, Boston Scientific initiated a Customer Notification worldwide. On May 21, 2007 Boston Scientific expanded this field action to a recall/removal status for Germany. Affected customers were notified in Germany on May 24, 2007.