Date: 01/12/2022
Product type: Defect, Medical Devices
Company Announcement Date: January 12, 2022
FDA Publish Date: January 12, 2022
Product Type: Medical Devices
Reason for Announcement: Hub cap and seal on the proximal end of the device handle may detach during use
Company Name: Oscor Inc.
Brand Name: Oscor
Product Description: Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheath