# Class II recall Z-0134-2027: Jenavalve Technology Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0134-2027 |
| Recalling firm | Jenavalve Technology Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | JenaValve Trilogy Delivery Catheter, Size 23MM  REF: TRILOGY-DC-S |
| Reason | Delivery Catheter may  have sleeve liner separation that results in difficulty or inability  to  deploy heart valve device. |
| Quantity | 111 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. |
| Recall initiated | 2026-07-31 |
| Reported | 2026-10-21 |
| Firm location | Irvine, CA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 15 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0134-2027%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.