Recall Z-0135-2027
- Recall number
- Z-0135-2027
- Event number
- 99697
- Firm
- Jenavalve Technology Inc.
- Firm FEI
- 3012148004
- Product code
- NPT
- Status
- Open, Classified
- Initiated
- 2026-07-31
- Posted
- 2026-10-09
- Root cause
- Nonconforming Material/Component
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.