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Terminated

Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M00456620, M00456630, M00456650, M00456700, M00456710 and M00456760. Manufactured by Thomas Medical Products, Inc. Product is intended for use to facilitate the percutaneous introduction of various types of cardiovascular catheters into either the right or left side of the heart. The sheath may be exchanged and used for left sided placement, after transseptal puncture has first been obtained by another sheath.

FDA Recall Z-1072-2009 · Posted 2009-04-09

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeDYB
Date Initiated2008-12-24
Date Terminated2010-04-06
Product Quantity31,340 of all units

Reason for Recall

The marker band may detach from the sheath and a clinical failure could result in an embolism.

Firm 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.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072719CONVOY ADVANCED DELIVERY SHEATHBoston Scientific Corp · 2008-03-07K034061MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATHBoston Scientific Corp · 2004-01-30K022067CONVOY ADVANCED DELIVERY SHEATHBoston Scientific · 2002-09-11K013866CONVOY ADVANCED DELIVERY SHEATH KITBoston Scientific · 2001-12-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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