Boston Scientific Corporation is recalling 68 units of AMS Artificial Urinary Sphincter components because some packages are mislabeled. Specifically, packages labeled as a Pressure Regulating Balloon (UPN 72400024) may actually contain a Control Pump (UPN 72400098). This recall affects units distributed worldwide, including 15 US states. No injuries or incidents have been reported to date.
The mismatch between the external label and the internal medical device could cause surgical delays or lead to the installation of an incorrect component during a procedure. This poses a risk to patients receiving these urological implants.
Quantity: 16 units; Potential to contain the device incorrectly labeled as a Pressure Regulating Balloon.
Quantity: 52 units; Product mislabeled as a Pressure Regulating Balloon but may contain a Control Pump.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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