JenaValve Trilogy Delivery Catheters
The JenaValve Trilogy Delivery Catheter may have sleeve liner separation that can cause difficulty or inability to deploy the heart valve device.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Jenavalve Technology Inc. recalled the Jenavalve Trilogy Delivery Catheter because the Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy the heart valve device. The recall began July 31, 2026, and was added to the FDA's Enforcement Report on October 9, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Match the UDI-DI and lot code listed under your product.
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
- UDI-DI
- 00850000898141
- Lot
- DS-040826-005
- DS-040926-002
- DS-042326-001
- DS-042826-007
- DS-042926-008
- DS-050826-005
- DS-051526-001
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
- UDI-DI
- 00850000898134
- Lot
- DS-040826-003
- DS-042326-003
- DS-042726-006
- DS-042826-005
- DS-050426-007
- DS-050626-002
- DS-050626-006
- DS-050626-009
- DS-050726-005
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
- UDI-DI
- 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
Details
- Company began the recall
- Event ID
- 99697
- Company
- Jenavalve Technology Inc.
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
