FDA DeviceClass INotable

FDA Recall: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-1

Date: 2026-06-03
Brand: Bolton Medical Inc.
Category: Medical Device
FDA Class: Class I

Description

Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

Hazard

Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

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