FDA-Device2026-10-21Class IIPROCESSING DEFECT
JenaValve Trilogy Delivery Catheter (25MM) recalled for sleeve liner separation risk
What this means
JenaValve Trilogy Delivery Catheter (Size 25MM, REF: TRILOGY-DC-M) may experience separation of the sleeve liner, which can prevent or delay deployment of the heart valve device during surgery. This affects 108 units distributed across the US and several European countries.
- If you have one of the affected lot numbers (DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001), do not use it.
- Contact JenaValve Technology Inc. or your medical device supplier immediately for a replacement or corrective action.
- Healthcare providers should verify lot numbers before any scheduled procedures.
The agency's original wording
Hazard
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
108 units
Manufactured in
4 Cromwell, Irvine, CA, United States
Products
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0135-2027More Jenavalve recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.