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January 11, 2022
Oscor Recalls Models of Destino Twist and Guidestar Steerable Guiding Sheaths
January 11, 2022—Oscor Inc. announced it is voluntarily recalling 14 lots of Destino Twist 14 F, model DST1405525, and the Guidestar 14 F, model D141103, down to the user level. The products are steerable guiding sheaths intended for the introduction of diagnostic and therapeutic devices into the human vascular, including but not limited to intracardiac, renal, or other peripheral placements; they cannot be used for neural placements.
According to the company, the recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product. The affected models were distributed worldwide to distributors and hospitals from June 8 to November 30, 2021.
Oscor advised that the models of these devices have been found to have increased risk of the hub cap and seal on the proximal end of the device handle detaching during use. This could lead to bleeding and/or air embolism for the patient during intracardiac, renal, or other peripheral placements procedures.
There were two Medical Device Reports to the FDA related to the detachment, stated the company.
The FDA recall notification and the company announcement are on the FDA MedWatch website.
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