FDA (Devices) recall action 85322

Cardiac Assist, Inc recalled 8 products on 2020-05-20

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2020-05-20
Critical: 0
Units: 135

Why these products were recalled

Failure to prime due to an assembly error

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

HighFDA (Devices)··2020-05-20
Cardiac Assist Recalls 15 TandemHeart Pumps Due to Assembly Error
Cardiac Assist, Inc. is recalling 15 TandemHeart pump kits due to an assembly error that may prevent the device from priming.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-05-20
Cardiac Assist Recalls 13 TandemLife Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 13 TandemLife Kits because an assembly error may prevent the pump from priming. The kits provide temporary circulatory support.
Product
TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Category
Distribution
0 states
HighFDA (Devices)··2020-05-20
Cardiac Assist Recalls Six TandemHeart Pump Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling six TandemHeart pump kits because an assembly error may prevent the device from priming.
Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Category
Distribution
0 states
HighFDA (Devices)··2020-05-20
Cardiac Assist Recalls TandemHeart Pump Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 10 TandemHeart Pump Kits because an assembly error may prevent the device from priming.
Product
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-05-20
Cardiac Assist Recalls TandemHeart Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling five TandemHeart pump kits because an assembly error may prevent the device from priming.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-05-20
Cardiac Assist Recalls TandemLung Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling two TandemLung Kit units because an assembly error may prevent the pump from priming.
Product
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Category
Distribution
0 states
HighFDA (Devices)··2020-05-20
Cardiac Assist Recalls TandemHeart ProtekDuo Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 46 TandemHeart ProtekDuo Kits due to an assembly error that may cause failure to prime.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-05-20
Cardiac Assist Recalls 38 TandemHeart ProtekDuo Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 38 TandemHeart ProtekDuo Kits because an assembly error may prevent the pump from priming.
Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Category
Distribution
0 states