FDA Recalls Thoracic Stent-Graft Systems Over Manufacturing Size Defect
Bolton Medical has recalled 640 units of RELAY PRO thoracic stent-graft systems worldwide because the products may be shorter than their packaging indicates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a manufacturing defect (product shorter than packaging indicates) in a critical surgical implant. No reported illnesses or injuries exist, but the defect represents a risk of harm in thoracic surgical applications.
Plain-English summary
Bolton Medical Inc. is recalling 640 units of the RELAY PRO thoracic stent-graft system. According to the FDA, the products may be shorter than stated on the packaging.
The affected devices were distributed worldwide to medical facilities in the United States, United Kingdom, France, Germany, Italy, Netherlands, Chile, Japan, and China. Multiple lot numbers and product configurations are included in this recall.
No illnesses or injuries related to this defect have been reported. Healthcare providers with affected units should contact Bolton Medical Inc. for instructions regarding replacement or further guidance.
The recalled product
- Product
- RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
- Manufacturer
- Bolton Medical Inc.
- Hazard
- Affected units
- 640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDIUDI/DI 00843576100954
- REF 28-N4-22-159-22S
- Lot Numbers: B210719245
- B210619174
- UDI/DI 00843576100831
- REF 28-N4-24-099-24S
- Lot Numbers: B220323028
- B211222140
- UDI/DI 00843576150423
- REF 28-N4-24-099-24U
- Lot Numbers: 2204210157
- 2204210158
- 2208230256
- 2208250035
- UDI/DI 00843576100961
- REF 28-N4-24-159-24S
- Lot Numbers: B220104035
- B220824113
- B210612293
- B220201173
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Bolton Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Bolton Medical Inc.
See all →- SevereRelayPro thoracic stent-graft clasp may not release from delivery system
FDA (Devices) · 2026-06-03
- HighRELAY PRO Thoracic Stent-Graft System recalled for incorrect size
FDA (Devices) · 2024-04-03
- HighTREO Abdominal Stent-Graft Label Does Not Match Actual Device Size
FDA (Devices) · 2023-06-14
- HighThoracic Stent-Graft System Recalled Due to Dimensional Defect
FDA (Devices) · 2023-01-25
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