Reported Oct 21, 2026 · Ongoing
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
Jenavalve Technology Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Jenavalve Technology Inc. · 4 Cromwell · Irvine, CA · 92618-1816
Is this the product you have?
- JenaValve Trilogy Delivery Catheter
- Size 23MM REFTRILOGY-DC-S
- Lot codes and dates
- GTIN - 00850000898134/ Lot
DS-040826-003 DS-042326-003DS-042726-006DS-042826-005DS-050426-007DS-050626-002DS-050626-006DS-050626-009DS-050726-005
- GTIN - 00850000898134/ Lot
- Amount recalled
- 111 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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