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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:186306

BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

Official recall number

Z-1460-2021

Evidence summary

Product code
MRM
Recall status
Terminated
Event initiated
March 08, 2021
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1460-2021

Field note

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