Z-2089-2008

NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET...

Name: Z-2089-2008 NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET...
Creator: Boston Scientific Cupertino, Corporation
Published: 2006-05-15
License: https://open.fda.gov/license/

Boston Scientific Cupertino, Corporation / initiated 2006-05-15 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Cupertino, Corporation began a recall of NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET tray manufactured by Boston Scientific Corp... on 2006-05-15. The reason FDA records is "Tip may detach from stent delivery system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2089-2008
Status: Terminated
Initiated: 2006-05-15
Posted: 2008-09-16
Terminated: 2008-09-25
Recalling firm: Boston Scientific Cupertino, Corporation
Product: 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.
Product code: NIM Stent, Carotid
Reason for recall: Tip may detach from stent delivery system.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 1326 units
Distribution: 188 consignees throughout Europe received the product.
Product codes and lots: 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

Product code NIM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)