Bolton Medical recalls RELAY PRO thoracic stent-graft systems that may be shorter than packaging indicates. Affected units include specific model numbers and lot numbers listed in the recall notice.
The product may be shorter than packaging indicates
Bolton Medical is recalling certain RELAY PRO thoracic stent-graft systems because they may be shorter than the packaging claims. This could lead to improper sizing during medical procedures, though the recall does not specify a risk of injury.
The product may be shorter than the packaging indicates, which could result in improper sizing during medical procedures. However, the recall does not specify that this causes injury or serious harm.
Patients who have received the recalled RELAY PRO thoracic stent-graft systems from Bolton Medical. Medical professionals using these systems for procedures are also at risk if they have the affected models.
Check the product's UDI/DI number and lot numbers listed in the recall notice. Affected units include specific model numbers like REF 28-M4-22-190-22S and lot numbers such as B210925203.
Review the UDI/DI number and lot numbers on the product to see if they match the affected units listed in the recall notice.
No, the recall does not require stopping use. The product may be shorter than stated, but the recall does not specify a risk of injury.
Check the UDI/DI number and lot numbers on your product against the list provided in the recall notice.
The recall does not specify a remedy, so there is no action required beyond checking if your product matches the affected list.
We’ve drafted a message you can send Bolton Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0997-2023 — Bolton Medical Bolton Medical Hello, I own a Bolton Medical that is covered by recall Z-0997-2023 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.
