Boston Scientific recalls AMS Artificial Urinary Sphincter Control Pumps with mislabeled packaging that may contain the wrong device. Affected units have specific UPN and serial numbers. Consumers should check their product details.
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Boston Scientific is recalling AMS Artificial Urinary Sphincter Control Pumps that have mislabeled packaging. This could mean the device contains a Control Pump instead of a Pressure Regulating Balloon, which might cause improper function. If you own this product, check the serial numbers and UPN to see if it's affected.
The packaging may incorrectly label a Control Pump as a Pressure Regulating Balloon. This could lead to improper device function, but the recall does not mention serious injury risks. The hazard is related to incorrect labeling rather than immediate danger.
People who own the AMS Artificial Urinary Sphincter Control Pump with the specific UPN number 72400098 and serial numbers listed in the recall. Those with medical devices for urinary control are most at risk.
Check the UPN number on the packaging (72400098) and the serial numbers listed: 1100366307, 1100366316, etc. The product was sold with specific expiration dates and lot numbers.
Verify the UPN number (72400098) and serial numbers listed in the recall to confirm if your device is affected.
The recall states there is a risk of mislabeled packaging, but it does not mention serious injury or death. The hazard is low risk as the device may not function properly if mislabeled.
Check the UPN number and serial numbers against the list provided in the recall. If your product matches, contact Boston Scientific for further instructions.
Look for the UPN number 72400098 and serial numbers listed: 1100366307, 1100366316, 1100366309, and others. The product was sold with specific expiration dates and lot numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0530-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0530-2025 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.
