Device evidence

device-recall:cfres:204544

Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body

Official recall number

Z-0649-2024

Evidence summary

Product code: DYB
Recall status: Open, Classified
Event initiated: November 07, 2023
Root cause: Process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0649-2024