Cardiac Diagnostic Implant Recalled for Premature Device Failure
Angel Medical Systems is recalling The Guardian cardiac diagnostic implants due to devices reaching end of service prematurely. The affected units may fail to properly detect acute coronary syndrome events.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a cardiac diagnostic device where premature failure could prevent the device from detecting acute coronary syndrome events as intended. While no illnesses or injuries have been reported, the hazard represents a significant risk of harm to affected patients.
Plain-English summary
Angel Medical Systems is recalling The Guardian Model AMSG3-E cardiac diagnostic implants. The Guardian is designed to detect the onset of acute coronary syndrome (ACS) events and alert patients to seek urgent medical care.
The device is subject to recall because units are reaching end of service prematurely. Approximately 548 units are affected across 11 states including Arizona, Arkansas, California, Florida, Georgia, Indiana, Louisiana, Nevada, Oklahoma, South Carolina, and Texas.
Patients who have received The Guardian implant should contact their healthcare provider for further guidance regarding their device.
The recalled product
- 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…
- Manufacturer
- Angel Medical Systems, Inc.
- Affected units
- 548
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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