Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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

U.S. FDA — Device Enforcement · United States · 2023-09-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1140-2025
Date of alert: 2023-09-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Angel Medical Systems, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00850012625001

Reported risk: Device reaching End of Service prematurely.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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