Z-1071-2009

Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0...

Name: Z-1071-2009 Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0...
Creator: Boston Scientific Corp
Published: 2008-12-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-12-24 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corp began a recall of Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0, M0045665ST0, M0045667ST0, M0045670ST0, M0045672ST0... on 2008-12-24. The reason FDA records is "The marker band may detach from the sheath and a clinical failure could result in an embolism". 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-1071-2009
Status: Terminated
Initiated: 2008-12-24
Posted: 2009-04-09
Terminated: 2010-04-06
Recalling firm: Boston Scientific Corporation
Product: Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0, M0045665ST0, M0045667ST0, M0045670ST0, M0045672ST0, M0045675ST0, M0045676ST0, M0045690ST0, M0045890ST0, M0045748ST0 and M0045749ST0. Manufactured by Thomas Medical Products, Malvern, PA. Product is intended for use to facilitate the intracardiac placement of interventional devices.
Product code: DYB Introducer, Catheter
Reason for recall: The marker band may detach from the sheath and a clinical failure could result in an embolism.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm initiated the recall on December 24, 2009 and notified consignees via "Urgent Company Initiated Medical Device Recall - Immediate Action Required" letters which explain the reason for the recall and request the affected product be returned to the Boston Scientific Corporation Distribution Center. An amendment letter with two additional Convoy Advanced Delivery Sheath Kit models (M0045748ST0 and M0045749ST0) was sent to affected customers on January 27, 2009. Direct questions about this recall to your local Sales Representative.
Quantity in commerce: 31,340 of all units
Distribution: Worldwide Distribution.
Product codes and lots: Batch Numbers: S1721 4 S1899 6 S2103 9 S2287 6 S2497 2 S1724 9 S1903 2 S2105 6 S2287 7 S2513 9 S1732 2 S1913 1 S2109 5 S2295 6 S2522 7 S1733 8 S1913 2 S2115 2 S2295 9 S2524 0 S1735 6 S1913 3 S2118 9 S2296 4 S2536 0 S1737 1 S1926 5 S2123 4 S2297 1 S2553 7 S1737 2 S1930 1 S2135 6 S2299 4 S2553 8 S1737 4 S1956 3 S2151 1 S2299 5 S2555 1 S1757 4 S1962 0 S2156 4 S2301 4 S2557 8 S1766 6 S1962 1 S2161 5 S2305 1 S2562 9 S1766 7 S1964 4 S2166 4 S2306 9 S2566 1 S1766 8 S1970 4 S2166 5 S2307 0 S2566 4 S1792 6 S2015 1 S2166 6 S2308 9 S2567 6 S1792 S2015 S2180 S2309 and S2579.

Product code DYB

K013866Class IConvoy Advanced Delivery Sheath KitBoston Scientific / cleared 2001-12-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)