Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The
Summary
The FDA issued a Class II for Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: by Angel Medical Systems, Inc.. Reason: Device reaching End of Service prematurely..
Details
Source
Device Recall
External ID
Z-1140-2025
Action Date
2025-02-19
Status
Ongoing
Category
device
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.
Lot/Code Info: 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.
Quantity Affected: 548 units
Reason for Recall
Device reaching End of Service prematurely.
Distribution
US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-01
Company
Eatontown, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Angel Medical Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Angel Medical Systems, Inc. have FDA actions?
This is the only FDA action we have on record for Angel Medical Systems, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1140-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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