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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device with a functional defect (failure to prime) that poses a risk of harm, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
Cardiac Assist, Inc. is recalling 46 units of the TandemHeart pump ProtekDuo Kit - DL3 (Product 5720-3118). The recall is due to an assembly error that may result in the device failing to prime. The affected kits provide temporary extracorporeal circulatory system support and are distributed nationwide in the United States.
The specific serial numbers affected by this recall are listed in the agency's official documentation. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare providers and consumers should stop using the affected kits and contact Cardiac Assist, Inc. for instructions on how to return or replace the product.
The recalled product
- 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
- Cardiac Assist, Inc
- Category
- Medical Device — Cardiac Support
- Affected units
- 46
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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