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Boston Scientific Corporation Recall: AMS Artificial Urinary Sphincter Control Pump

Boston Scientific Corporation Recall: AMS Artificial Urinary Sphincter Control Pump is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: AMS Artificial Urinary Sphincter Control Pump; Reason for recall: Potential for mislabeled packaging in which a de

Recalling firmBoston Scientific Corporation
ProductAMS Artificial Urinary Sphincter Control Pump
Reason for recallPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionWorldwide - 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,
Recall initiated20241028
Recall numberZ-0530-2025
Categorydevice
StateMA
CountryUnited States

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