Recall Z-0530-2025 ยท EZY Device, Incontinence, Mechanical/Hydraulic
Boston Scientific Corporation
AMS Artificial Urinary Sphincter Control Pump
| Date | Nov 25, 2024 (initiated Oct 28, 2024) |
| Status | Open, Classified |
| Reason | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) |
| Root cause | Error in labeling |
| 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). |
| Quantity | 16 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.