Bolton Medical Issues Urgent Recall of Relay Pro Thoracic Stent Graft Over Unclasping Fault

Bolton Medical announced an urgent Class I recall of its Relay Pro Thoracic Stent Graft System, specifically the non-bare stent configuration 32 mm and larger.

The recall was triggered because the proximal clasp can become disconnected from the outer control tube, preventing the graft from unclasping from the delivery system. In such cases, clinicians may need to convert to open surgical repair, which carries a risk of death.

The FDA classified the recall as the most serious type, and Bolton Medical has instructed users to stop using the devices immediately, isolate any affected inventory, and return the products to the manufacturer. Updated guidance letters were sent to customers on April 23 and June 5.