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FDA Warns Boston Scientific Recalls Transcarotid Catheter Over Tip Separation Issue

GateNews

According to the FDA, Boston Scientific recalls specific batches of its ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus due to arterial sheath catheter tip separation or partial separation. As of July 9, the defect has caused 1 serious injury and no deaths. Separated tips may require endovascular intervention or surgery for removal.

The affected devices are specific production batches of both ENROUTE system variants used in transcarotid procedures.

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