FDA-Device2026-10-21Class IIPROCESSING DEFECT
Jenavalve Trilogy 27MM Delivery Catheter recalled for potential valve deployment failure
What this means
Jenavalve Technology Inc. is recalling certain Trilogy Delivery Catheter devices (27MM, REF: TRILOGY-DC-L) because the sleeve liner may separate inside the catheter. This separation can make it difficult or impossible to properly deploy the heart valve device during surgery.
- If your hospital or clinic has this device in stock, contact Jenavalve Technology Inc. immediately for guidance.
- Do not use affected catheters until you receive instructions from the manufacturer or FDA.
- Check the device reference number (TRILOGY-DC-L) and size (27MM) to confirm whether your inventory is affected.
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
143 units
Manufactured in
4 Cromwell, Irvine, CA, United States
Products
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0136-2027More Jenavalve recalls
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