Class IIDeviceOngoing

Jenavalve Technology Inc.

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.

Details

Recall number: Z-0135-2027
Event ID: 99697
Recall initiated: Jul 31, 2026
Classified: Oct 9, 2026
Reported: Oct 21, 2026
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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Irvine, CA, United States
Lot / code info: GTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001