Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA
This recall has been terminated (originally issued August 9, 2007).
- 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
- Official Source
- View on FDA website ↗
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.