Drug recall
AMS Artificial Urinary Sphincter Control Pump
FDA recall event 95608 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 95608 |
|---|---|
| Recall numbers | Z-0530-2025, Z-0531-2025 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | AMS Artificial Urinary Sphincter Control Pump, AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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) |
| Initiation date | Oct 28, 2024 |
| Report date | Dec 4, 2024 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 3005099803 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: