Z-1465-2021 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
- 8 UNITS
Product Description
BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - 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 84737505 84737521 84738497 84738498 84738995 84738997 84739001 84739004