CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report
The Guardian System The Guardian recalled by Angel Medical Systems
Angel Medical Systems is recalling The Guardian System The Guardian, distributed nationwide in the US. The recall was initiated on 1 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1140-2025
- FDA event ID
- 96126
- Recalling firm
- Angel Medical Systems, Eatontown, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Sep 2023
- FDA classified
- 11 Feb 2025
- Reported
- 19 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Sep 2023 | Recall initiated by company | |
| 11 Feb 2025 | Classified by FDA | +529 days |
| 19 Feb 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device reaching End of Service prematurely.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
Nationwide ArkansasArizonaCaliforniaFloridaGeorgiaIndianaLouisianaNevadaOklahomaSouth CarolinaTexas
Questions about this recall
Why was it recalled?
Device reaching End of Service prematurely.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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