Boston Scientific recalls AMS 800 Artificial Urinary Sphincter belt cuffs labeled 4.5 cm but actually 4.0 cm. This mislabeling could cause improper fit and complications. Affected units include specific part numbers and lot numbers.
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Boston Scientific is recalling AMS 800 Artificial Urinary Sphincter belt cuffs that were mislabeled as 4.5 cm but are actually 4.0 cm. This could lead to improper fit and potential complications for users. The recall affects specific part numbers and lot numbers.
The belt cuff was labeled as 4.5 cm but is actually 4.0 cm. This size difference could cause improper fit, potentially leading to complications like leakage or discomfort. However, the risk is not severe enough to cause serious injury in normal use.
People who own the AMS 800 Artificial Urinary Sphincter belt cuff with part number 72400161 and lot number 23973023 are affected. Those with medical devices requiring precise sizing are at higher risk.
Check for the part number 72400161 and lot number 23973023 on the AMS 800 belt cuff. The product was sold with the label indicating 4.5 cm but is actually 4.0 cm.
Look for part number 72400161 and lot number 23973023 on the AMS 800 belt cuff.
The AMS 800 belt cuff was mislabeled as 4.5 cm but is actually 4.0 cm, which could cause improper fit and potential complications.
Check the product label for part number 72400161 and lot number 23973023. If you have these identifiers, contact Boston Scientific for further instructions.
The recall indicates a potential for improper fit, but the hazard is not severe enough to cause serious injury in normal use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2442-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2442-2019 from Boston Scientific. 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.
