Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Recalled by Angel Medical Systems, Inc. Due to Device reaching End of Service prematurely.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Angel Medical Systems, Inc. directly.
Affected Products
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.
Quantity: 548 units
Why Was This Recalled?
Device reaching End of Service prematurely.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Angel Medical Systems, Inc.
Angel Medical Systems, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report