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Oscor Recalls Destino Twist Steerable Guiding Sheath

oscor jan14 lt

Palm Harbor, Florida -based Oscor Inc. is recalling 14 lots of Destino Twist Steerable Guiding Sheath, the U.S. Food and Drug Administration announced. The products were found to have increased risk of the hub cap and seal on the proximal end of the device handle detaching during use.

The recall involves Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The recall is limited to the two model numbers and lot numbers.

The product is used as a steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices into the human vascular, including intracardiac, renal or other peripheral placements, among others. It cannot be used for neural placements. The product is provided sterile, one unit per pouch / tray for details.

The affected Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 were distributed Worldwide to distributors and hospitals from June 8, 2021 to November 30, 2021.

The agency noted that the detachment of the hub cap and seal on the proximal 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.

The recall was initiated after Oscor reported two Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle.

The company is arranging for the return of all recalled products.

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