FDA MedWatch - Destino Twist Steerable Guiding Sheath by Oscor:
U.S. Food and Drug Administration sent this bulletin at 01/13/2022 06:58 AM EST
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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TOPIC: Destino Twist Steerable Guiding Sheath by Oscor: Recall - Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use
AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology, Nephrology
ISSUE: Oscor is recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103. 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.
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 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.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product is steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices into the human vascular, including but not limited to intracardiac, renal or other peripheral placements; it cannot be used for neural placements.
RECOMMENDATIONS:
Oscor is notifying its distributors and customers by email and is arranging for the return of all recalled products.
Customers with questions regarding this recall can contact Oscor’s Customer Relations Group.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
