Recall Z-1140-2025
Angel Medical Systems, Inc. · initiated September 1, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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.
Reason for recall
Device reaching End of Service prematurely.
FDA-determined cause: Process control
Action taken
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
Details
- Recall number
- Z-1140-2025
- Initiated
- September 1, 2023
- Posted by FDA
- February 11, 2025
- Product code
- QBI – Acute Coronary Syndrome Event Detector
- Quantity
- 548 units
- Distribution
- US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
- Recalling firm
- Angel Medical Systems, Inc., Eatontown, NJ