Bolton Medical Inc.: System, Endovascular Graft, Aortic Aneurysm Treatment
Recall Summary Bolton Medical is recalling certain RelayPro Thoracic Stent-Graft Systems used to treat aortic aneurysms because the proximal clasp may disconnect from the outer control tube, which could prevent the stent graft from being released properly from its delivery system during the procedure. The affected devices were distributed worldwide, including in Puerto Rico, Argentina, Chile, Canada, Colombia, Mexico, and the United Kingdom. This is a Class III recall, the lowest severity classification for device recalls.
- Recalling firm
- Bolton Medical Inc.
- Product
- RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U...
- Reason
- Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-22
- Status
- Open, Classified
- Distribution
- Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8b92e4ec-adc2-45f4-93e5-c3b1a5a22094