Device recall
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
- Recall number
- Z-0136-2027
- Event id
- 99697
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Jenavalve Technology Inc.
- Report date
- Oct 21, 2026
- Posted
- Oct 9, 2026
- Initiated
- Jul 31, 2026
- Center classification date
- Oct 9, 2026
- Product code
- NPT
- Device type
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Reason
- Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- Root cause
- Nonconforming Material/Component
- Quantity
- 143 units
- Code info
- 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
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Irvine, CA, United States