Angel Medical Systems, Inc. has recalled 548 units of The Guardian (model AMSG3-E) cardiac diagnostic implant system. This device is designed to detect heart events and warn patients to seek medical care, but it is reaching its end of service much earlier than expected due to battery failure. While no injuries or incidents have been reported, the premature battery depletion may leave patients without the necessary heart monitoring and warning functions.
The device's battery may fail prematurely, causing the implant to stop monitoring the heart or fail to provide a critical warning during a cardiac event. This could lead to a delay in a patient seeking life-saving medical treatment.
Correction or Replacement
Quantity: 548 units; Recalled for device reaching End of Service prematurely.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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