Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TandemLife ECLS Procedure Kit - V24/A17 Recalled by Cardiac Assist, Inc Due to The kit contained a 29Fr ProtekDuo cannula instead...
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
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
Quantity: 11 kits
Why Was This Recalled?
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
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