JenaValve Trilogy Delivery Catheter recall (Jenavalve Technology Inc.)

Medical deviceClass IIOngoing

Summary: Jenavalve Technology Inc. is recalling JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L. Reason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

What is being recalled

JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L

Why

Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

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. (states named: Arizona, California, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Jenavalve Technology Inc. · all medical device recalls · recalls from July 2026

Official FDA record