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Brand Name: The Guardian System recallZ-1140-2025 · Angel Medical Systems, Inc. · initiated Sep 1, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Angel Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Device reaching End of Service prematurely.

FDA root cause category: Process control

What the company is doing

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

Recall details

Recall number
Z-1140-2025
Status
Open, Classified
Initiated by the company
Sep 1, 2023
Posted by the FDA
Feb 11, 2025
Recalling firm
Angel Medical Systems, Inc.
Quantity
548 units
Product code
QBI
FDA submissions
P150009
Distribution
US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.

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.

Code information (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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