FDA-Device2026-10-21Class IIPROCESSING DEFECT
Jenavalve Trilogy Delivery Catheter 23MM recalled for sleeve liner separation risk
What this means
The Jenavalve Trilogy Delivery Catheter (Size 23MM, REF: TRILOGY-DC-S) may experience separation of the sleeve liner, which could make it difficult or impossible to deploy the heart valve device during the procedure. The FDA has classified this as a Class II recall.
- If you have this device or know of a patient who received it, contact Jenavalve Technology Inc. or your healthcare provider immediately.
- Do not use affected catheters. Check the device serial number and lot information against the recall list.
- Healthcare facilities should quarantine affected inventory and review patient records for devices used.
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
111 units
Manufactured in
4 Cromwell, Irvine, CA, United States
Products
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0134-2027More Jenavalve recalls
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