# FDA recall Z-0530-2025

> **Boston Scientific Corporation** · Class II · device recall initiated 2024-10-28.

## Product

AMS Artificial Urinary Sphincter Control Pump

## 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)

## 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, Spain, Sweden, Switzerland, and Taiwan.

## Key facts

- **Recall number:** Z-0530-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-28
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0530-2025

## Citation

> AI Analytics. FDA recall Z-0530-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0530-2025. Source: US FDA. Licensed CC0.

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