Device evidence

device-recall:cfres:209645

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

Official recall number

Z-3136-2024

Evidence summary

Product code: DSP
Recall status: Open, Classified
Event initiated: August 08, 2024
Root cause: Software design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-3136-2024