URGENT: MEDICAL DEVICE RECALL UPDATE (REMOVAL)

Device: Relay Pro Thoracic Stent Graft System Non-Bare Stent Configuration

>= 32 mm diameter (28-N4 devices)

Dear Valued Customer,

On April 22, 2026, Bolton Medical Inc. operating as Terumo Aortic issued a voluntary medical device recall. This updated communication contains a revised recall strategy (removal). Changes have been highlighted for your awareness. 

The purpose of this letter is to notify consignees that Bolton Medical Inc., operating as Terumo Aortic, is conducting a voluntary medical device recall (removal) of Relay Pro Thoracic Stent Graft System, N4: Non-Bare Stent Configuration 32mm and above.  Failures to release the partially deployed stent-graft from the delivery system have occurred. 

Description of the Problem:

Through post-market surveillance, we have received complaints where 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.  Our investigation has concluded that the manufacturing process may contribute to this device problem.

Risk to Health:

Bolton Medical has received 4 complaints within the last 8 months associated with this failure mode, 3 of which resulted in death including 1 aortic perforation, and 2 conversions to open surgery which resulted in patient deaths due to stroke. In these cases, proximal clasps disconnected from the outer control tube. This prevented the stent grafts from being released from the delivery system.

This failure mode cannot 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.

There is no risk to patients that have already received the stent graft.  The issue is isolated to Relay Pro NBS N4 with support wires (32mm and above) delivery system.  Relay Pro NBS N4 without support wires (30mm and below) and Relay Pro Bare Stent M4 are not impacted by this recall. 

Corrective Action:

The root cause has been identified as a manufacturing fixture associated with the Relay Pro NBS with support wires.  Bolton Medical is in the process of making manufacturing changes to eliminate the risk of this failure mode.  New product will become available once all required validations are completed and regulatory approvals are received.  Terumo will communicate when product is available again. 

Actions To Be Taken by Customer:

1.       Discontinue use of the Relay Pro immediately.

2.       Review your Relay Pro Inventory and immediately isolate affected inventory to prevent future use.   

3.       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. 

4.       Complete Appendix 1 the number of units in your control to be returned to Terumo.  The form is required even if you do not have product on hand. 

5.       Contact Terumo6732@sedgwick.com to initiate the return process. 

6.       Return affected product with a copy of Appendix 1 to:

Sedgwick, Inc.

Attn: Event 6732

2670 Executive Dr., Suite A

Indianapolis, IN 46241

Please be assured that we take the safety and quality of our products very seriously and remain committed to supporting you with high quality products.  If you have additional questions, please reach out to your Terumo Aortic Representative or contact us at Market_Actions-TMC@terumomedical.com. 

Adverse Health events may be reported to the FDA's MedWatch Adverse Event Reporting program via:

Web: MedWatch website at http://www.fda.gov/medwatch

Phone: 1-800-FDA-1088 (1-800-332-1088)

Mail: MedWatch, HF-2, FDA, 5600 Fisher’s Lane, Rockville, MD 20852-9787

On behalf of Bolton Medical, Inc.

Kimberly Feitl

Vice President, Quality

Devices Included - All products within expiry for the following product models:

MEDICAL DEVICE RECALL NOTICE UPDATE (Removal)

Please return completed form to Terumo6732@sedgwick.com include a copy with the device returns.

Appendix 1: Recall Notice Acknowledgement Form

FSN2026-002 revision 2

Account Information:

By signing below, I acknowledge:
· Receipt of the recall notice and confirm that I understand the contents.

· I have communicated the information to users in my organization or other organizations I transferred products to.

· All products in my facility have been isolated and are being returned.