Angel Medical Systems, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1140-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 1, 2023

Date Posted: February 19, 2025

Recall Number: Z-1140-2025

Event ID: 96126

Reason for Recall:

Device reaching End of Service prematurely.

Status: Ongoing

Product Quantity: 548 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated