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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:215937

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

Official recall number

Z-0021-2026

Evidence summary

Product code
QTF
Recall status
Open, Classified
Event initiated
August 29, 2025
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0021-2026