Cardiac Assist Recalls TandemHeart Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling five 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Cardiac Assist, Inc. is recalling five units of the TandemHeart Kit - TS62/A15 (Product 5710-6215). These medical devices are used to provide temporary extracorporeal circulatory system support and locally deliver an anticoagulant through an infusion system.
The recall was initiated 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 00142681, 00142683, 00142949, 00142950, and 00142951.
Healthcare facilities and users should check their inventory for these specific serial numbers. If a unit is found, it should be removed from service and the recalling firm contacted for instructions on return or replacement.
The recalled product
- Product
- TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - 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
- 5
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: 00142681 00142683 00142949 00142950 00142951
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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