Source

SFDA- Saudi Food & Drug Authority.

https://ade.sfda.gov.sa/Fsca/PublishDetails/235

Product

AXIOS™ Stent and Electrocautery Enhanced Delivery System.

Manufacturer

Boston Scientific Corporation.

Local agent

Lab Technology Centre LLC

The affected products

Specific lots of the AXIOS™ Stent and Electrocautery Enhanced Delivery System, detailed in the attachment.

Reason

The potential of outer sheath distal black tip detaching from the device.

Action

1. Please immediately discontinue use of the Boston Scientific product reported in the attachment and remove all of the affected units from your inventory, regardless of where these units are stored in your facility. Segregate the units in a secure place, pending return to Boston Scientific.

Comments

Healthcare professionals are encouraged to report any adverse events Suspected to be associated with the above device or any other medical device to Department of Medical Device Control through the E-mail: vigilance-md@moh.gov.om