FDAFDA · Food and drugs·Recall number Z-0530-2025
AMS Artificial Urinary Sphincter Control Pump
Published December 4, 2024 · Recall initiated: October 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- 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.
- Lot
- UPN Number: 72400098. GTIN Number: 00878953000688. Lot Number: 32487464. Serial Numbers: 1100366307, 1100366316, 1100366309, 1100366317, 1100366310, 1100366319, 1100366311, 1100366320, 1100366312, 1100366321, 1100366313, 1100366323, 1100366314, 1100366324, 1100366315, 1100366325. Expiration Date: 09/24/2028
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.