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BIOTRONIK Inc recalls BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular ta
Recalled April 28, 2021 · FDA recall Z-1453-2021 · BIOTRONIK
Hazard
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) · FDA Class II
Units
2881 UNITS
Sold at
US: Nationwide OUS: Worldwide
Description
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Product
BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Manufacturer(s)
BIOTRONIK Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →