fda_recall · device_recall · critical

Bolton Medical Inc. — Class I recall: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-3…

Event date
2026-06-03 00:00:00Z
Observed
2026-07-09 22:52:24Z
Source ID
Z-2160-2026
Payload hash
faf33c99ed5f589cc19c34e7

Summary

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

Informational only. Not legal, financial, or medical advice.