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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with a functional defect (failure to prime) that poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Cardiac Assist, Inc. is recalling 38 units of the TandemHeart pump, assembled as the ProtekDuo Kit - DL29 (Product 5720-2916). The recall is due to an assembly error that may cause the device to fail to prime. The device provides temporary extracorporeal circulatory system support and locally delivers an anticoagulant through the infusion system.
The affected units were distributed nationwide in the United States. The recall covers specific serial numbers, including 00142569 through 00142936. The agency has classified this as a Class II recall.
Healthcare providers and consumers should check their inventory for the affected serial numbers. If a unit is found, it should be removed from service and returned to Cardiac Assist, Inc. according to the recall instructions.
The recalled product
- 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.
- Manufacturer
- Cardiac Assist, Inc
- Category
- Medical Device — Cardiac Support
- Affected units
- 38
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Cardiac Assist, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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