Angel Medical Systems, Inc. recalls Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The…

Recall date

September 1, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1140-2025

FDA classification

Class II

Brand / firm

Angel Medical Systems, Inc.

Sold / distributed

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

Why it was recalled

Device reaching End of Service prematurely.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.