Medical device manufacturer, Boston Scientific, is voluntarily recalling its Chariot Guiding Sheath. The affected material numbers and batch expiration date range are shown below:

• Material number:
  • H74939277645110, H74939277690210, H74939277690220, H74939277845210, H74939277745210, H74939277645210, H74939277745110, H74939277665110, H74939277690110, H74939277765110, H74939277545110, H74939277690120, H74939277845110, H74939277790110, H74939277865110, H74939277545210, H74939277790220, H74939277665120, H74939277645220, H74939277645120, H74939277745120, H74939277790210, H74939277790120, 74939277890110, H74939277765120, H74939277865120, H74939277890120, H74939277845120, H74939277745220
• Batch expiration date range:
  • 31 March 2016 through 30 November 2018

The manufacturer has received fourteen complaints for shaft separation, four for distal shaft separation.

According to the manufacturer, the most severe outcome of this failure is embolism of device fragments.

The recall removal affects all UPNs. Further distribution or use of any remaining product affected by the recall should cease immediately. Product recall is on-going.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 23 November 2015