FDA Recall Database: Class I Recall: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers:… by Bolton Medical Inc.

Key facts

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers (additional items listed in FDA's full record) -- and the recall number Z-2160-2026. If it matches, stop using or distributing it and contact Bolton Medical Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Bolton Medical Inc. and the affected product is described in FDA's record as: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers (additional items listed in FDA's full record). FDA's stated reason for the recall is: Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.. The recall is tracked under FDA recall number Z-2160-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

Bolton Medical Inc.’s FDA history

Argus HQ has recorded 1 total FDA action tied to Bolton Medical Inc.: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the FDA recall number for this event?

FDA recall number Z-2160-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

Bolton Medical Inc. recalled RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers (additional items listed in FDA's full record). FDA's record states the reason for recall as: Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.. The recall is logged under FDA recall number Z-2160-2026 with a Class I classification.

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