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Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary
Recalled May 20, 2020 · FDA recall Z-1952-2020 · Cardiac Assist
Hazard
Failure to prime due to an assembly error · FDA Class II
Units
46
Sold at
US Nationwide distributions.
Description
Failure to prime due to an assembly error
Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Manufacturer(s)
Cardiac Assist, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →