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# Bolton Thoracic Stent Recall is Class 1: FDA
- URL: https://www.fdaweb.com/bolton-thoracic-stent-recall-is-class-1-fda/
- Published: 2026-05-21T12:00:00.000Z
- Updated: 2026-09-14T13:39:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161182

FDA says the Bolton Medical 8/23 recall (correction) notice, with updated use instructions for all RelayPro Thoracic Stent Graft Systems, is a Class 1 recall, the most serious type of medical device recall. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/thoracic-stent-graft-recall-bolton-medical-removes-relay-pro-system?ref=fdaweb.com) says the company also recommended that customers use alternative stent-graft options before using the affected RelayPro devices until mitigation measures are in place.

Bolton indicated 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, FDA says. It said difficulties in releasing the stent graft may result in delay of the procedure, stent graft displacement, and an inability to release the stent graft.

As of 4/23, the company had reported three deaths associated with the issue, including one aortic perforation and two conversions to open surgery that resulted in patients’ deaths due to stroke, the agency notice says.