Boston Scientific product recalled over labeling errors

Recall date

October 28, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Boston Scientific Corporation recalls AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O

Recall number

Z-0531-2025

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

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,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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