Class I (most serious) Medical Device Z-2160-2026 Ongoing

FDA Class I recall: Bolton Medical RelayPro Thoracic Stent-Graft System labeling update over delivery-system release risk

Bolton Medical Inc. ・Reported Jun 3, 2026

The FDA has classified a Class I recall (recall_number: Z-2160-2026) of Bolton Medical's RelayPro Thoracic Stent-Graft System, involving a labeling update. The proximal clasp may disconnect from the outer control tube, which may prevent the stent graft from being released from the delivery system.

Recall overview (primary data)

ClassificationClass I (most serious)
Product typeMedical Device
Recalling firmBolton Medical Inc.
ReasonLabeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
DistributionWorldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.
Recall initiated2026-04-22

Key points

The affected device is Bolton Medical Inc.'s RelayPro Thoracic Stent-Graft System (various sizes).
The reason is a labeling update concerning proximal clasp disconnection from the outer control tube, which may prevent the stent graft from being released from the delivery system.
The FDA classification is the most serious, Class I (recall_number: Z-2160-2026).
Distribution included international markets such as Puerto Rico and within the United States, with status Ongoing.
Report date is June 3, 2026, and the device type is Devices.

The RelayPro Thoracic Stent-Graft System consists of a stent graft (a fabric vessel reinforced by a metal frame that is placed inside a blood vessel to support a weakened vessel wall) used in the treatment of conditions such as thoracic aortic aneurysm, together with a delivery system (the set of catheter-based instruments that carry the graft to the target site and deploy it). This Class I recall involves a labeling update relating to the possibility that the proximal clasp (the fastener that temporarily holds the central end of the graft, the end nearest the heart) disconnects from the outer control tube, which may prevent the graft from being released from the delivery system as intended.

Among the FDA's recall classifications, Class I is the most serious category, used when there is a reasonable probability that use of or exposure to the product will cause serious harm to health or death. A recall accompanied by a labeling update is notable because it addresses the issue not only through removal of product but also by conveying information on precautions and procedures to the clinical setting, encouraging appropriate handling. Endovascular treatment of the thoracic aorta is widely used as an approach that can reduce physical burden compared with open surgery, and the reliability of delivery and deployment is directly tied to procedural safety.

For high-risk devices that are permanently implanted, such as aortic stent grafts, information governing the delivery and release process that makes implantation possible is critical, not only the integrity of the device itself. This case illustrates that device performance and accompanying information (labeling) together constitute safety, and that for medical devices whose supply chains span the U.S. mainland, Puerto Rico, and overseas, recall information must be communicated consistently across borders. More broadly, it underscores that post-market surveillance (the system for tracking and responding to malfunctions and adverse events after a product reaches the market) forms a foundation for patient safety alongside quality control at the design and manufacturing stages.

Why it matters

For high-risk implantable medical devices, safety depends not only on the quality of the device itself but also on the alignment between the delivery-and-release process and the accompanying labeling. For manufacturers with distribution networks spanning the U.S. mainland, Puerto Rico, and overseas, a Class I recall highlights the importance of post-market surveillance and cross-border regulatory readiness, while clinicians need to identify affected devices and share information.

FAQ

What is a stent graft?

It is a fabric vessel reinforced by a metal frame that is placed inside a blood vessel to support a weakened vessel wall from within. It is used in the treatment of conditions such as thoracic aortic aneurysm.

How serious is a Class I recall?

It is the most serious category in the FDA's recall classification, used when there is a reasonable probability that use of or exposure to the product will cause serious harm to health or death.

What is the specific issue in this case?

It is a labeling-update issue: the proximal clasp may disconnect from the outer control tube, which may prevent the stent graft from being released from the delivery system during placement.

Sources (primary)

Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.

#FDA#Class I recall#medical device#stent graft#thoracic aorta#Bolton Medical#post-market surveillance

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