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/A15, Product: 5710-6215 - 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: 00142681 00142683 00142949 00142950 00142951
View official government recall

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