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.
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 10 units of the TandemHeart Pump Kit (Product 5120-0000). The recall is due to an assembly error that may cause the device to fail to prime. The TandemHeart Pump Kit 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 specific serial numbers for the recalled units are 00142577, 00142578, 00142579, 00142656, 00142675, 00142944, 00142946, 00142947, 00142960, and 00142961.
Healthcare providers and facilities should check their inventory for these specific serial numbers. If a unit is found, it should be removed from service and returned to Cardiac Assist, Inc. according to the company's instructions.
The recalled product
- 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.
- Manufacturer
- Cardiac Assist, Inc
- Category
- Medical Device — Cardiac Support
- Affected units
- 10
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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