FDA Device recall Z-0135-2027
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
- FDA Device
- Class II
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class II recall of JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M by Jenavalve Technology, citing delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0135-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-31 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | Jenavalve Technology |
| Distribution | US |
Product
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Reason
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Identifiers
| 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
Other recalls by Jenavalve Technology
- JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
FDA Device · Class II · 2026-10-21 · Jenavalve Technology - JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
FDA Device · Class II · 2026-10-21 · Jenavalve Technology
All Jenavalve Technology recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0135-2027%22
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