Two Models of Oscor’s Destino Twist and Guidestar Recalled
Palm Harbor, Fla.-based Oscor is recalling 14 lots of its Destino Twist steerable guiding sheath and Guidestar models, used for delivering diagnostic and therapeutic devices into the human vasculature.
Detachment of the hub cap and seal could lead to bleeding at the proximal end of the device or to an air embolism during intracardiac, renal or other peripheral placement procedures, the company said.
The voluntary recall includes 14 lots of Destino Twist 14F model DST1405525 and Guidestar 14F model D141103. The two affected models were distributed from June 8 to Nov. 30, 2021.
Oscor has sent two medical device reports to the FDA related to detachment of the hub cap and seal.