RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U - Labeling u⁠pdate concerning pro

Source: FDA | Recall date: 06/03/2026

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Affected product: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U

Summary: 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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