FDA Device recall Z-0136-2027
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
- 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 27MM REF: TRILOGY-DC-L 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-0136-2027 |
| 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 27MM REF: TRILOGY-DC-L
Reason
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Identifiers
| code_info | GTIN - 00850000898158/ Lot: DS-040926-004, DS-041026-008, DS-041026-009, DS-042226-006, DS-042226-007, DS-051526-004, D…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 |
|---|
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 25MM REF: TRILOGY-DC-M
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-0136-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.