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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:188412

FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

Official recall number

Z-2309-2021

Evidence summary

Product code
LIT
Recall status
Terminated
Event initiated
July 14, 2021
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2309-2021

Field note

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