Official recall notice

FDA DeviceClass INotable

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

Recall date
2026-06-03
FDA class
Class I

Why it was recalled

Hazard

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

Product description

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

Verify with the official notice →
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