The Recall Desk
HighFDA (Devices)·Z-0997-2023·Announced 2023-01-25

Thoracic Stent-Graft System Recalled Due to Dimensional Defect

Bolton Medical's RELAY PRO thoracic stent-graft system is being recalled because affected units may be shorter than their packaging indicates. The recall affects 129 units distributed worldwide.

What this means for you

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: This is an FDA Class II medical device recall involving a dimensional defect on a surgical implant used in thoracic procedures. The hazard—undersized stent-grafts—could compromise device placement and effectiveness. However, no injuries, adverse events, or deaths have been reported, placing this in the risk-of-harm category without documented harm.

Plain-English summary

Bolton Medical Inc. is recalling the RELAY PRO thoracic stent-graft system. Affected units may be shorter in length than indicated on their packaging.

The recall addresses a dimensional discrepancy between the product's actual length and the length specified on the packaging label. No adverse events or injuries have been reported in connection with this recall.

The recall involves 129 units distributed worldwide, including in the United States and the countries of the United Kingdom, France, Germany, Italy, the Netherlands, Chile, Japan, and China. Specific affected lot and reference numbers are documented in the FDA recall.

More information about this recall, including affected lot and reference numbers, is available from the FDA under recall number Z-0997-2023 or from Bolton Medical Inc.

The recalled product

Product
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
Manufacturer
Bolton Medical Inc.
Category
Medical Device — Thoracic Stent-Graft
Hazard
Affected units
129

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)

  • UDI/DI 00843576100268: REF 28-M4-22-190-22S
  • Lot Numbers: B210925203 UDI/DI 00843576149731
  • REF 28-M4-24-150-24U
  • Lot Numbers: 2204210015
  • 2208250004
  • 2208250003
  • UDI/DI 00843576149618
  • REF 28-M4-26-095-26U
  • Lot Numbers: 2112210189
  • UDI/DI 00843576149748
  • REF 28-M4-26-155-26U
  • Lot Numbers: 2208240053
  • 2208250164
  • 2208220204
  • UDI/DI 00843576100039
  • REF 28-M4-28-095-28S
  • Lot Numbers: B220211367
  • B220129307
  • B220211163
  • UDI/DI 00843576149625

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.

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Same hazard · dimensional defect

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