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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:203834

Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.

Official recall number

Z-0409-2024

Evidence summary

Product code
DRS
Recall status
Open, Classified
Event initiated
October 04, 2023
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0409-2024

Field note

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