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Boston Scientific received three reports of embolism that occurred outside of the pelvis. These events occurred as a result of inadvertent placement of Spaceoar gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis. As a result of these three reports, Boston Scientific conducted a comprehensive investigation of all spaceoar embolism complaints received where patient harm was reported. As part of these investigation efforts, Boston Scientific identified potential contributing factors and best practices regarding hydrogel placement during all spaceoar procedures that we are incorporating into the IFU. The updated IFUs will be packaged with Spaceoar systems after all applicable regulatory approvals are obtained for the IFU updates. This product advisory contains the recommended IFU updates.
Recall start date: Feb 24, 2022
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts
United States, 01752