FDA Early Alert: Thoracic Stent Graft Issue from Bolton Medical
Published: 04/28/2026
Sources:
- Food and Drug Administration
Relevant To:
- Critical Access Hospitals,
- Hospitals
Bolton Medical has issued an Urgent Medical Device Recall (Correction) notice providing updated use instructions for all Relay Pro Thoracic Stent Graft System, N4: Non-Bare Stent Configuration 32mm and above.
As of April 23, Bolton Medical has reported three deaths associated with this issue, including one aortic perforation and two conversions to open surgery which resulted in patient deaths due to stroke.
What To Do
- Bolton Medical recommends the following actions:
- Consider u…