- Recalling firm
- Jenavalve Technology Inc.
- Reason for recall
- Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- Affected products (lot / model / serial)
- GTIN - 00850000898134/ Lot: DS-040826-003 DS-042326-003, DS-042726-006, DS-042826-005, DS-050426-007, DS-050626-002, DS-050626-006, DS-050626-009, DS-050726-005
- Units affected
- 111 units
- Distribution pattern
- 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.
- Firm location
- Irvine, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0134-2027
- Recall initiated
- July 31, 2026
- FDA classification date
- October 9, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99697
- Last updated on HTM Vibe
- October 27, 2026
