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Boston Scientific Corporation recalls AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Recalled December 4, 2024 · FDA recall Z-0531-2025 · Boston Scientific
Hazard
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) · FDA Class II
Units
52 units
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 Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.
Description
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Product
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →