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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:194830

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1

Official recall number

Z-1488-2022

Evidence summary

Product code
NIK
Recall status
Open, Classified
Event initiated
June 22, 2022
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1488-2022