Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Perfusion Pack Recalled by LivaNova USA Due to 4-way stopcocks and stopcock manifold assembled in certain...
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 LivaNova USA directly.
Affected Products
Perfusion Pack, Rx only, Sterile EO
Quantity: 483
Why Was This Recalled?
4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.
Where Was This Sold?
This product was distributed to 38 states: AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, ME, MD, MA, MI, MS, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, WI
About LivaNova USA
LivaNova USA has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report