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.
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 involves a high-risk medical device where a functional failure (failure to prime) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cardiac Assist, Inc. is recalling two units of the TandemLung Kit - DL31 (Product 5730-3118). The recall is due to an assembly error that may cause the TandemHeart pump to fail to prime.
The affected units have serial numbers 00142473 and 00142606. These kits were distributed nationwide in the United States. The TandemLung Kit provides temporary extracorporeal circulatory system support and locally delivers an anticoagulant through the infusion system.
Consumers and healthcare facilities should check their inventory for these specific serial numbers and stop using the affected units. They should contact Cardiac Assist, Inc. for further instructions on how to return or replace the devices.
The recalled product
- 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.
- Manufacturer
- Cardiac Assist, Inc
- Category
- Medical Device — Cardiac Support
- Affected units
- 2
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: 00142473 00142606
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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