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.
FDA Recall Z-2089-2008 · Posted 2008-09-16
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Recalling FirmBoston Scientific Cupertino, Corporation
Recall StatusTerminated
Product CodeNIM
Date Initiated2006-05-15
Date Terminated2008-09-25
Product Quantity1326 units
Reason for Recall
Tip may detach from stent delivery system.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
188 consignees throughout Europe received the product.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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