JenaValve Trilogy Delivery Catheter recall (Jenavalve Technology Inc.)
Medical deviceClass IIOngoing
Summary: Jenavalve Technology Inc. is recalling JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M. 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 25MM REF: TRILOGY-DC-M
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 - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001
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
| Recall number | Z-0135-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 31, 2026 |
| Reported | October 21, 2026 |
| Company | Jenavalve Technology Inc. |
| Company location | Irvine, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 108 units |
More recalls from Jenavalve Technology Inc. · all medical device recalls · recalls from July 2026