The FDA is aware that 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. The notice also recommends customers consider using alternative stent-graft options prior to use of impacted RelayPro devices until mitigation measures are in place.
The RelayPro Thoracic Stent-Graft System is a minimally invasive device used to repair damaged or weakened sections of the thoracic aorta (e.g., aneurysms, dissections, or tears) by placing a stent graft that reinforces the vessel and maintains blood flow.
Bolton Medical stated that in some cases the graft is unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. This may be recognized by the user as a lack of resistance felt when sliding the apex holder back accompanied by a failure to release the proximal stent. The implant cannot be recaptured at this stage in the procedure. This failure mode is not able to be recognized until it occurs during the procedure.
Difficulties in releasing the stent graft may result in delay of procedure, stent graft displacement, and an inability to release the stent graft. This may require conversion to open surgical repair to release the clasp and can result in patient death. This failure mode can occur without prior warning and no device-based bailout method has been identified for this specific scenario.
As of April 23, 2026, 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.
On April 23, 2026, Bolton Medical sent all affected customers a letter recommending the following actions:
- Consider use of alternative stent-graft options prior to use of impacted RelayPro devices until mitigation measures are in place.
- In the event that there is difficulty releasing the proximal stent and no resistance is encountered when sliding the apex holder back, the user should first attempt the existing bailout techniques described in the Instructions for Use (IFU) prior to committing to any alternative course of action. If the problem persists, there are no additional device bailout methods available and clinical judgment should guide timely decision-making, including consideration of conversion to open surgery.
- Inform all users of Relay Pro of the additional guidance for managing cases where the stent graft cannot be released from the delivery system. If devices have been transferred to another facility, please provide them with a copy of the notification and instruct them to follow the actions in this section.
- Keep a copy of the Urgent Medical Device Recall (Correction) notice with the IFU and post a copy where devices are stored.
The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
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