Device evidence

device-recall:cfres:180520

TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Official recall number

Z-1954-2020

Evidence summary

Product code: KFM
Recall status: Terminated
Event initiated: March 06, 2020
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1954-2020