Z-1463-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- March 8, 2021
- Termination Date
- April 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 UNITS
Product Description
BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - 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 Pattern
US: Nationwide OUS: Worldwide
Code Information
Serial Number 84736231 84737026 84737315 84737560 84738576 84744864 84744872 84745476 84748008 84748843 84749243 84749246 84751394 84751632 84753554 84755167 84761228