Medical Device Recall: 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
Angel Medical Systems, Inc. · September 1, 2023
Reason for Recall
Device reaching End of Service prematurely.
Product Description
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.
Distribution
US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
States Affected
NATIONWIDE
Quantity Affected
548 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1140-2025
Status: ongoing
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