Bolton Medical Recalls RelayPro Thoracic Stent-Graft System
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Bolton Medical Inc. is recalling RelayPro Thoracic Stent-Graft System devices due to a labeling update concerning potential proximal clasp disconnection.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 23, 2026 and geographically references Worldwide. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
Bolton Medical Inc. initiated a voluntary recall of the RelayPro Thoracic Stent-Graft System. The recall involves a labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Which Products Are Affected
The affected product is the RelayPro Thoracic Stent-Graft System (various sizes). Reference numbers include 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, 28-N4-42-114-42U, 28-N4-42-159-38U, 28-N4-42-159-42U, 28-N4-42-204-38U, 28-N4-42-204-42U, 28-N4-42-259-42U, 28-N4-44-114-44U, 28-N4-44-164-40U, 28-N4-44-164-44U, 28-N4-44-209-40U, 28-N4-44-209-44U, 28-N4-44-259-40U, 28-N4-44-259-44U, 28-N4-46-114-46U, 28-N4-46-164-42U, 28-N4-46-164-46U, 28-N4-46-209-42U, 28-N4-46-209-46U, and 28-N4-46-259-42U. All lots are affected. Recall number Z-2160-2026. Distribution is worldwide, including the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, and the United Kingdom.
What You Should Do
Customers should follow instructions provided in the updated labeling. Contact Bolton Medical Inc. for additional guidance on affected devices.
Why This Matters
This Class I recall addresses a potential issue that may prevent proper deployment of the stent graft during procedures.
Source
FDA recall Z-2160-2026 (event ID 98729)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,886 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to June 23, 2026.
Frequently Asked Questions
Common questions about this FDA recall.