Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System

The recommendations provided below have changed. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

The FDA is aware that Bolton Medical has issued an Urgent Medical Device Recall (Removal) recommending that certain devices be removed from where they are used or sold. Affected devices:

• Relay Pro Thoracic Stent Graft System, N4: Non-Bare Stent Configuration 32mm and above.

What to Do

Discontinue use of the Relay Pro system immediately and return them to the manufacturer.

On April 23, Bolton Medical sent all affected customers a letter recommending changes to the instructions for use. On June 5, they sent an updated customer letter with updated recommendations. The following actions are included:

• Discontinue use of the Relay Pro immediately.  
• Review your Relay Pro Inventory and immediately isolate affected inventory to prevent future use.  
• If devices have been transferred to another facility, please provide them with a copy of this notification and instruct them to follow the actions in this section.  
• Return affected product to the manufacturer.    

Reason for Recall

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. Please be advised that 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, 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.

Device Use

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.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Terumo Aortic at Market_Actions-TMC@terumomedical.com.

Additional FDA Resources

1. FDA Enforcement Report 
2. CDRH Medical Device Recall Database

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Timeline of Communication Updates