NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET tray manufactured by Boston Scientific Corp, Natick, MA.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- May 15, 2006
- Posted
- September 16, 2008
- Terminated
- September 25, 2008
- Recall Number
- Z-2089-2008
- Quantity
- 1326 units
- Firm Location
- Cupertino, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Tip may detach from stent delivery system.
Distribution
188 consignees throughout Europe received the product.
Lot / Code Info
All products distributed between 04/07/2005 through 04/28/2006, Lot numbers (batch numbers are the same as lot numbers, without preceeding letter): c45301, c50101, c50202, c50203, c50204, c50205, c50301, c50302, c50303, c50304, c50305, c50401, c50402, c50403, c50404, c50405, c50406, c50501, c50502, c50503, c50601, c50602, c50701, c50702, c50703, c50704, c50801, c50802, c50803, c50804, c50805, c50901, c50902, c50903, c50904, c51001, c51002, c51003, c51101, c51102, c51201, c51202, c51301, c51302, c51303, c51304, c51305, c51401, c51402, c51403, c51404, c51405, c51601, c51602, c51701, c51702, c51801, c51802, c51803, c51804, c52101, c52201, c52202, c52203, c52401, c52402, c52403, c52501, c52502, c52503, c52504, c52505, c52601, c52602, c52603, c52701, c52702, c52703, c52704, c52801, c52802, c52901, c52902, c52903, c52904, c53001, c53003, c53103, and c53801
Root Cause
Process control
Action Taken
The firm issued notification letters and information sheets to consignees describing the risks. The firm requested the products be returned to the firm. If you have questions, contact the firm at 408-517-2800.