Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex Internationa
FDA device recall Z-1161-2007 · posted 2007-08-09 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NIM
- Quantity affected
- 2487
- Distribution
- Worldwide, including USA, France, Italy, Germany, Belgium, Cyprus, Austria, Spain, Finland, Netherlands, Luxembourg, Romania , Czech Republic, Poland, Israel, Hungary, New Zealand, and Switzerland.
- Date initiated
- 2007-05-01
- Date posted
- 2007-08-09
- Date terminated
- 2008-03-02
- Location
- Natick, MA
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