Jenavalve Technology Inc. recalls JenaValve Trilogy Delivery Catheter
- Recalling company
- Jenavalve Technology Inc.
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 31, 2026
- Reported
- Oct 21, 2026
- 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.
- Status
- Ongoing
- Quantity
- 143 units
- Lot / codes
- 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
- Company location
- Irvine, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0136-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0136-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.