fda-safety ·
Thoracic stent graft recall for Relay Pro system
The FDA says Bolton Medical removed the Relay Pro thoracic stent graft system after reports the graft may not fully release, which can be life-threatening.
If you have a Bolton Medical Relay Pro thoracic stent graft, the Food and Drug Administration (FDA) safety notice says the graft may not unclasp from its delivery system.
This problem may require conversion to open surgical repair and may result in patient death.
The notice does not say whether existing implants are affected or what your next step should be.
What to do
- Contact your healthcare professional or the implanting team for guidance related to the Relay Pro system recall.
What we explain about this
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