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Spaceoar system
Official notice
7 Mar 2022
Last checked
7 Mar 2022
An official Health Canada notice concerns Spaceoar system. 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 Published 2022-03-07.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63966
Official notice
2022-03-07
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Boston Scientific, Spaceoar System.
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Source & status
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Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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