Abbott Medical is recalling 6 Aveir Leadless Pacemaker (LP) Ventricular Devices (models LSP202V and LSP112V) because a manufacturing issue may cause the batteries to fail earlier than expected. The recall affects devices distributed to hospitals and medical facilities in Florida, South Carolina, and West Virginia, as well as healthcare providers in Spain. No injuries have been reported, but a premature battery failure could cause the device to stop providing essential heart pacing therapy to the patient.
A manufacturing issue exposed these pacemakers to higher than normal temperatures, which can lead to the battery failing before its intended service life ends. If the battery fails, the device may stop monitoring the heart rate or providing the pacing therapy required to regulate the heart, which could lead to serious medical complications for the patient.
Distributed in FL, SC, and WV.
Distributed outside of the United States (Spain).
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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