medical Class II Updated 2020-05-20

Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemHeart Kit - T

Recalled Product

TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Hazard / Issue

Failure to prime due to an assembly error

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 00142938 00142941 00142942 00142970 00142971 00142972
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