Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29 Recalled by Cardiac Assist, Inc Due to Failure to prime due to an assembly error
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cardiac Assist, Inc directly.
Affected Products
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Quantity: 38
Why Was This Recalled?
Failure to prime due to an assembly error
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cardiac Assist, Inc
Cardiac Assist, Inc has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report