Bolton Medical recalls
4 official recalls and safety alerts involving Bolton Medical since 2023-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Bolton Medical or the relevant agency.
- 2026-06-03
USBolton Medical Inc. recalls RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U…
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
FDA · DeviceBolton Medical Inc.Worldwide - distribution in the US Territory of Puerto Rico and the countries…Official notice →- 2024-04-03
- US
Bolton Medical Inc. recalls RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part…
The stent-graft inside the delivery system was the incorrect size.
FDA · DeviceBolton Medical Inc.Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The…Official notice → - 2023-06-14
- US
Bolton Medical Inc. recalls The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg…
Potential for the incorrect size stent-graft than the printed carton label.
FDA · DeviceBolton Medical Inc.Worldwide distribution - US Nationwide distribution in the states of FL, NY,…Official notice → - 2023-01-25
- US
Bolton Medical Inc. recalls RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
The product may be shorter than packaging indicates
FDA · DeviceBolton Medical Inc.Worldwide distribution - US Nationwide and the countries of UK, France,…Official notice →