FDA recall Z-1453-2021

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.

Reason for recall

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

Distribution

US: Nationwide OUS: Worldwide

Key facts

Status

Terminated

Initiation date

2021-03-08

Report date

2021-04-28

Termination date

2023-04-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Oswego, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1453-2021