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Open, Classified

AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O

FDA Recall Z-0531-2025 · Posted 2024-11-25

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeEZY
Date Initiated2024-10-28
Product Quantity52 units

Reason for Recall

Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)

Firm Action

Boston Scientific notified their consignees on about 10/28/2024 via letter. Consignees were instructed to immediately discontinue use and segregate the affected products, notify all personnel that need to be aware, notify customers if further distributed, arrange for the return of affected product and complete and return the Reply Verification Tracking Form (RVtF).

Root Cause

Error in labeling

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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