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Bolton Medical Recalls
5 recalls on record · January 25, 2023 to June 3, 2026 · Medical Devices
Recalls by year
23
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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 3, 2026Medical DevicesFDA
Bolton Medical Inc. recalls RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-
Hazard: Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
April 3, 2024Medical DevicesFDA
Bolton Medical Inc. recalls RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, s
Hazard: The stent-graft inside the delivery system was the incorrect size.
June 14, 2023Medical DevicesFDA
Bolton Medical Inc. recalls The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Gr
Hazard: Potential for the incorrect size stent-graft than the printed carton label.
January 25, 2023Medical DevicesFDA
Bolton Medical Inc. recalls RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
Hazard: The product may be shorter than packaging indicates
January 25, 2023Medical DevicesFDA
Bolton Medical Inc. recalls RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
Hazard: The product may be shorter than packaging indicates