Bolton Medical Inc. FDA Recalls

5 recalls on file across devices, 1 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-Class IApr 22, 2026Labeling update concerning proximal clasp disconnection from	Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent gr	Class IDevices	Apr 22, 2026
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sClass IIFeb 22, 2024The stent-graft inside the delivery system was the incorrect	The stent-graft inside the delivery system was the incorrect size.	Class IIDevices	Feb 22, 2024
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-GrClass IIMay 3, 2023Potential for the incorrect size stent-graft than the printe	Potential for the incorrect size stent-graft than the printed carton label.	Class IIDevices	May 3, 2023
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXXClass IIDec 20, 2022The product may be shorter than packaging indicates	The product may be shorter than packaging indicates	Class IIDevices	Dec 20, 2022
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXXClass IIDec 20, 2022The product may be shorter than packaging indicates	The product may be shorter than packaging indicates	Class IIDevices	Dec 20, 2022