# FDA recall Z-2442-2019

> **Boston Scientific Corporation** · Class II · device recall initiated 2019-07-19.

## Product

AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm  Part Number: 72400161

## Reason for recall

Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..

## Distribution

MN

## Key facts

- **Recall number:** Z-2442-2019
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-19
- **Report date:** 2019-09-11
- **Termination date:** 2020-04-23

- **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-2442-2019

## Citation

> AI Analytics. FDA recall Z-2442-2019. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2442-2019. Source: US FDA. Licensed CC0.

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