Cardiac Assist Recalls 13 TandemLife Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 13 TandemLife Kits because an assembly error may prevent the pump from priming. The kits provide temporary circulatory support.
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 failure to prime could prevent necessary circulatory support, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Cardiac Assist, Inc. is recalling 13 units of the TandemLife Kit (Product 5740-0000). The TandemHeart pump, which is assembled into these kits, provides temporary extracorporeal circulatory system support and locally delivers an anticoagulant through the infusion system.
The recall is due to an assembly error that may cause the pump to fail to prime. The affected units were distributed nationwide in the United States. The specific serial numbers for the recalled units are 00142463, 00142464, 00142465, 00142469, 00142470, 00142471, 00142472, 00142478, 00142479, 00142480, 00142481, 00142482, and 00142483.
Healthcare providers and consumers should check their inventory for these specific serial numbers. If a unit is affected, it should be removed from service and returned to Cardiac Assist, Inc. according to the company's instructions.
The recalled product
- Product
- TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - 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
- 13
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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