Device evidence

device-recall:cfres:160823

Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

Official recall number

Z-0506-2018

Evidence summary

Product code: MCW
Recall status: Terminated
Event initiated: September 14, 2017
Root cause: Labeling mix-ups
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0506-2018