FDA Enforcement
Class II
Terminated
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.
Recall: Z-1465-2021
·
Reported April 28, 2021
Enforcement
- Recall Number
- Z-1465-2021
- 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 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
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Code Info
Serial Number 84737505 84737521 84738497 84738498 84738995 84738997 84739001 84739004
Distribution
US: Nationwide OUS: Worldwide
Quantity
8 UNITS