Angel Medical Systems, Inc.: 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.

Recall number

Z-1140-2025

Recalling firm

Angel Medical Systems, Inc.

Product

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.

Status

Open, Classified

Initiated

2023-09-01

Posted

2025-02-11

Terminated

not on file

Reason

Device reaching End of Service prematurely.

Root cause

Process control

Action

On September 18, 2023, URGENT: MEDICAL DEVICE FIELD ACTION were sent to customers. Actions to be taken by Physical/Site Avertix Medical Inc. recommends that all patients identified in the notification sheet included with this letter be checked and monitored as per the following recommendations. Patient Monitoring Recommendations: Avertix Medical Inc. recommends the following steps be taken for each such patient in this regard: 1) For the identified patients, consider reducing the interval of their 6-month regularly scheduled visits to 3-month intervals. At those visits, Avertix Medical personnel verify the battery voltage determine if it is as expected. 2) At these visits, remind patients to pay attention to the See Doctor Alerts the Guardian System Generates and to promptly notify their physician if they occur so they can be quickly evaluated. 3) Remind the patient that they can use their EXD to verify that the implanted device is working correctly by placing it up to within 2 inches of their implant location (chest) and pushing the EXD button. a. Two beeps mean the battery (and device) is functioning properly. b. One beep requires additional follow-up which includes making an appointment with their doctor to have a clinic visit so the device can be evaluated using a Physician Programmer. 4) Reinforce the fact that symptoms should never be ignored. Patients are trained at their programming visit after implant to never ignore symptoms and that training should be repeated with the patient at each scheduled visit. Acknowledging the Receipt of this Notification: Enclosed is an Acknowledgement and Receipt Form. Avertix Customer Service can assist you in completing this form and process. This information is essential to maintain field action effectiveness information required by the U.S. Food and Drug Administration. Type of Action Taken by Avertix: Avertix Medical Inc. is committed to providing the safest products possible to our physicians and patients. Once t

Quantity

548 units

Distribution

US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P150009"]

Product code

QBI

Firm FEI

3017374019

Firm city

Eatontown

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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