Cardiac Assist Recalls 15 TandemHeart Pumps Due to Assembly Error
Cardiac Assist, Inc. is recalling 15 TandemHeart pump kits due to an assembly error that 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 (extracorporeal circulatory support) with a functional defect (failure to prime). Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cardiac Assist, Inc. is recalling 15 units of the TandemHeart Kit - TS62/A17 (Product 5710-6217). The recall is due to an assembly error that may cause the pump to fail to prime. The TandemHeart pump 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 00142612, 00142614, 00142657, 00142658, 00142659, 00142660, 00142661, 00142663, 00142937, 00142938, 00142941, 00142942, 00142970, 00142971, and 00142972.
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 recall instructions.
The recalled product
- Product
- TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - 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
- 15
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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