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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:196484

TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..

Official recall number

Z-0228-2023

Evidence summary

Product code
DXE
Recall status
Open, Classified
Event initiated
September 30, 2022
Root cause
Process design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0228-2023