JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Official notice from a government agency or its published feed.
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Reason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and the countries of Germany, Denmark, Great Britain, Italy.
Reason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and the countries of Germany, Denmark, Great Britain, Italy.
Hazard: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
View the FDA enforcement report ↗ ← All reports