Bolton Medical recalls RelayPro Thoracic Stent-Graft Systems with specific reference numbers due to potential proximal clasp disconnection from the outer control tube, which may prevent stent graft release from delivery system.
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Bolton Medical is recalling several sizes of RelayPro Thoracic Stent-Graft Systems because a labeling update is needed to prevent the proximal clasp from disconnecting from the outer control tube. This could stop the stent graft from being released during medical procedures.
The proximal clasp may disconnect from the outer control tube during use, which could prevent the stent graft from being properly released from the delivery system. This labeling issue does not cause immediate harm but requires correction to ensure proper deployment.
Medical professionals who use the RelayPro Thoracic Stent-Graft System for procedures involving the thoracic area. Patients who have received this device are not affected by the recall.
Check the reference numbers listed in the recall notice: 28-N4-32-104-32U, 28-N4-32-164-28U, and other specific combinations. The product is used in medical procedures for thoracic stent grafts.
Verify if your device has any of the listed reference numbers: 28-N4-32-104-32U, 28-N4-32-164-28U, or other specific combinations provided in the recall notice.
No, patients who have received the device are not affected by this recall. The recall applies to devices used in procedures, not to patients who have already been implanted.
Check the reference numbers listed in the recall notice to see if your device is affected. If it is, contact Bolton Medical for guidance on next steps.
The recall involves a labeling update to prevent proximal clasp disconnection, but no specific fix is mentioned in the official notice.
We’ve drafted a message you can send Bolton Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2160-2026 — Bolton Medical Bolton Medical Hello, I own a Bolton Medical that is covered by recall Z-2160-2026 from Bolton Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
