FDA-Device2024-12-04Class II
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Boston Scientific Corporation
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)
Sold states
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.
Affected count
52 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0531-2025Don't want to check this manually?
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