Device evidence

device-recall:cfres:192430

Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.

Official recall number

Z-0927-2022

Evidence summary

Product code: NPV
Recall status: Open, Classified
Event initiated: March 02, 2022
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0927-2022