Device evidence

device-recall:cfres:191509

Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US

Official recall number

Z-0557-2022

Evidence summary

Product code: LIT
Recall status: Open, Classified
Event initiated: December 17, 2021
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0557-2022