Boston Scientific recalls AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O due to potential mislabeled packaging containing a Control Pump instead of Pressure Regulating Balloon.
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 a specific urinary sphincter device because some units were mislabeled in packaging. This could mean a patient receives a Control Pump instead of the intended Pressure Regulating Balloon, which might cause improper function or complications.
The device was labeled as a Pressure Regulating Balloon (UPN 72400024) but contained a Control Pump (UPN 72400098) in some packaging. This mismatch could lead to improper function of the urinary sphincter device, potentially causing complications for patients.
Patients with urinary sphincter devices who own the recalled model (UPN 72400024) are most at risk. The recall affects individuals who received the device with mislabeled packaging.
Check for the UPN number 72400024 on the packaging. The device has specific lot numbers and serial numbers listed in the recall notice. The expiration date is September 23, 2028.
Look for the UPN number 72400024 on the packaging to confirm it matches the recalled device.
The device was labeled as a Pressure Regulating Balloon but contained a Control Pump instead, which could lead to improper function.
Check the packaging for the UPN number 72400024. If it matches, contact Boston Scientific for further instructions.
The recall indicates a potential mislabeling risk, but no specific injuries have been reported. The risk is low as the issue involves packaging mislabeling rather than device failure.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0531-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0531-2025 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.
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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.
