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: Device reaching End of Service prematurely.

Code information: Model: AMSG3-E; UDI-DI: 00850012625001; Battery Lots A1946, A1947, A1948, A1949, A1950, A2003, A2004, A2031, A2032, A2033, A2034, A2035, A2036, A2038, A2039, A2040, A2041, A2042, A2043.

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