FDA Enforcement
Class II
Terminated
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.
Recall: Z-1463-2021
·
Reported April 28, 2021
Enforcement
- Recall Number
- Z-1463-2021
- Event ID
- 87549
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- BIOTRONIK Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 28, 2021
- Initiation Date
- March 8, 2021
- Classification Date
- April 21, 2021
- Termination Date
- April 25, 2023
- Address
- 6024 Jean Rd, N/A, Lake Oswego, OR, 97035-5571, United States
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
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Code Info
Serial Number 84736231 84737026 84737315 84737560 84738576 84744864 84744872 84745476 84748008 84748843 84749243 84749246 84751394 84751632 84753554 84755167 84761228
Distribution
US: Nationwide OUS: Worldwide
Quantity
17 UNITS