Summary
- Company Announcement Date:
- FDA Publish Date:
- 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:
-
- Product Description:
-
Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheath
Company Announcement
FOR IMMEDIATE RELEASE – January 10, 2022 – Palm Harbor, FL., Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal on the proximal end of the device handle detaching during use.