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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:123689

Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.

Official recall number

Z-0905-2014

Evidence summary

Product code
GEI
Recall status
Terminated
Event initiated
November 12, 2013
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0905-2014

Field note

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