Recall Z-1071-2009 ยท DYB Introducer, Catheter
Boston Scientific Corp
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.
| Date | Apr 9, 2009 (initiated Dec 24, 2008) |
| Status | Terminated |
| Reason | The marker band may detach from the sheath and a clinical failure could result in an embolism. |
| 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 | 31,340 of all units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013866 | CONVOY ADVANCED DELIVERY SHEATH KIT Boston Scientific, Dec 14, 2001 |