FDAFDA recall Z-0135-2027 · Oct 21, 2026
Jenavalve Technology Inc.: JenaValve Trilogy Delivery Catheter recall
Recall found
Product
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Reason for recall
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- GTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001
- Quantity
- 108 units
- Distribution
- 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.
- Recalling firm
- Jenavalve Technology Inc., Irvine, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-31
Source: openFDA enforcement record Z-0135-2027 · search recall number Z-0135-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.