Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use

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Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use

FOR IMMEDIATE RELEASE – January 11, 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.

RISK STATEMENT: The Destino Twist 14T Model DST1405525 & Guidestar 14F Model D141103 detachment of the hub cap and seal could lead to bleeding at the proximal end of the device and/or air embolism for the patient during intracardiac, renal or other peripheral placements procedures.
Oscor Inc. has reported two (2) Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle. The recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product.