FDA Device recall Z-1140-2025
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardi…
- FDA Device
- Class II
- ongoing
- Published 2025-02-19
On 2025-02-19 the FDA classified a Class II recall of Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardi… by Angel Medical Systems, citing device reaching End of Service prematurely.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1140-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-01 |
| Published | 2025-02-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Angel Medical Systems |
| Distribution | US |
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
Device reaching End of Service prematurely.
Identifiers
| code_info | Model: AMSG3-E; UDI-DI: 00850012625001; Battery Lots A1946, A1947, A1948, A1949, A1950, A2003, A2004, A2031, A2032, A20…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1140-2025%22
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