Z-1140-2025Class II

Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product...

Name: Z-1140-2025 Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product...
Creator: Angel Medical Systems, Inc.
Published: 2023-09-01
License: https://open.fda.gov/license/

Avertix Medical Inc. / initiated 2023-09-01 / Open, Classified / root cause: manufacturing process

FDA source

Angel Medical Systems, Inc. began a recall of Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic... on 2023-09-01. FDA classified it as Class II and gives the reason as "Device reaching End of Service prematurely". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1140-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-01
Posted: 2025-02-11
Recalling firm: Avertix Medical 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.
Product code: QBI Acute Coronary Syndrome Event Detector
Reason for recall: Device reaching End of Service prematurely.
Root cause tag: manufacturing process
FDA 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 in commerce: 548 units
Distribution: US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1140-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1140-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11

Product code QBI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)