Reported Feb 19, 2025 · Ongoing
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The…
Angel Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angel Medical Systems, Inc. · 40 Christopher Way Ste 201 · Eatontown, NJ · 07724-3327
Is this the product you have?
- Brand NameThe
- Guardian System Product NameThe
- Guardian Model/Catalog NumberModel
- AMSG3-E Product DescriptionThe 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
- Lot codes and dates
- ModelAMSG3-E
- UDI-DI
00850012625001Battery Lots A1946A1947A1948A1949A1950A2003A2004A2031A2032A2033A2034A2035A2036A2038A2039A2040A2041A2042A2043
- Amount recalled
- 548 units
Where it was sold
Why it was recalled
Device reaching End of Service prematurely.
This product could cause temporary or reversible health problems — stop using it.
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