# FDA recall Z-1140-2025

> **Angel Medical Systems, Inc.** · Class II · device recall initiated 2023-09-01.

## Product

Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

## Reason for recall

Device reaching End of Service prematurely.

## Distribution

US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.

## Key facts

- **Recall number:** Z-1140-2025
- **Recalling firm:** Angel Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-01
- **Report date:** 2025-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eatontown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1140-2025

## Citation

> AI Analytics. FDA recall Z-1140-2025. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-1140-2025. Source: US FDA. Licensed CC0.

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