Bolton Medical recalls RELAY PRO Thoracic Stent-Graft Systems with incorrect stent-graft size. Affected units have specific part numbers and lots. Contact for details.
The stent-graft inside the delivery system was the incorrect size.
Bolton Medical is recalling RELAY PRO Thoracic Stent-Graft Systems that contain an incorrect stent-graft size. This could lead to improper placement during medical procedures, potentially causing complications.
The stent-graft inside the delivery system was the incorrect size. This could result in improper placement during medical procedures, potentially causing complications such as improper blood flow or tissue damage.
Patients who received the recalled RELAY PRO Thoracic Stent-Graft System during medical procedures are affected. Medical professionals using the system for treatments are at risk of complications.
Check for part numbers listed in the recall: 28-M4-34-100-34U, 28-M4-30-095-30U, and others. Also look for specific lot numbers and UDI codes mentioned in the recall notice.
Review the part numbers and lot numbers listed in the recall notice to confirm if your device is affected.
The stent-graft inside the delivery system was the incorrect size, which could lead to improper placement during medical procedures.
Check for part numbers like 28-M4-34-100-34U, 28-M4-30-095-30U, and specific lot numbers listed in the recall notice.
Contact Bolton Medical directly to confirm if your device is affected and follow their instructions.
We’ve drafted a message you can send Bolton Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1383-2024 — Bolton Medical Bolton Medical Hello, I own a Bolton Medical that is covered by recall Z-1383-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
