FDA recall Z-1140-2025

Angel Medical Systems, Inc. · Class II · device

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

Status
Ongoing
Initiation date
2023-09-01
Report date
2025-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Eatontown, NJ, United States

Primary source

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