Boston Scientific Corporation 2024-12-04 Health serious FDA
Health · FDA · Recall #FDA-Z-0530-2025
AMS Artificial Urinary Sphincter Control Pump Recall
Issued December 4, 2024 · Boston Scientific Corporation
In December 2024, Boston Scientific Corporation recalled the AMS Artificial Urinary Sphincter Control Pump, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
What you should do
- 1 Stop using AMS Artificial Urinary Sphincter Control Pump right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Boston Scientific Corporation
- Category
- Health
- Recall date
- December 4, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Arge
- Recall number
- FDA-Z-0530-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 35 recalls in our database, including 13 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.