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.
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 high-risk medical device where a functional failure (failure to prime) poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cardiac Assist, Inc. is recalling six units of the TandemHeart pump, assembled into ProtekDuo Kit - DL31 RD (Product 5720-3631). The recall is due to an assembly error that may cause the device to fail to prime. The affected serial numbers are 00142676, 00142677, 00142678, 00142679, 00142680, and 00142910.
The affected products were distributed nationwide in the United States. The TandemHeart pump provides temporary extracorporeal circulatory system support and locally delivers an anticoagulant through the infusion system.
Healthcare providers and consumers should stop using the affected units and contact Cardiac Assist, Inc. for further instructions.
The recalled product
- 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.
- Manufacturer
- Cardiac Assist, Inc
- Category
- Medical Device — Cardiac Support
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 00142676 00142677 00142678 00142679 00142680 00142910
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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