United StatesWhat's being recalled
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Recalling firm: Jenavalve Technology Inc., Irvine, CA, United States.
How to identify it
GTIN - 00850000898134/ Lot: DS-040826-003 DS-042326-003, DS-042726-006, DS-042826-005, DS-050426-007, DS-050626-002, DS-050626-006, DS-050626-009, DS-050726-005 GTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001 GTIN - 00850000898158/ Lot: DS-040926-004, DS-041026-008, DS-041026-009, DS-042226-006, DS-042226-007, DS-051526-004, DS-051526-006, DS-060226-007, DS-060526-002, DS-060526-003, DS-060526-007
The hazard
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)