JenaValve Trilogy Delivery Catheter May Have Sleeve Liner Separation Risk
JenaValve Technology recalls 143 units of Trilogy Delivery Catheter Size 27MM REF: TRILOGY-DC-L due to potential sleeve liner separation causing deployment issues with heart valve devices.
Use caution until it’s fixed
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
What happened, in plain English
Jenavalve Technology recalls 143 units of their Trilogy Delivery Catheter (Size 27MM REF: TRILOGY-DC-L) because the catheter may have a sleeve liner separation that makes it difficult or impossible to deploy a heart valve device. Read more at govinfonow.com/recall/1765013-jenavalve-technology-inc-recalls-jenavalve-trilogy-delivery-catheter-size-27mm.
Source Summary by GovInfoNow · govinfonow.com/recall/1765013-jenavalve-technology-inc-recalls-jenavalve-trilogy-delivery-catheter-size-27mm · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0136-2027
Cite this page
“JenaValve Trilogy Delivery Catheter May Have Sleeve Liner Separation Risk.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1765013-jenavalve-technology-inc-recalls-jenavalve-trilogy-delivery-catheter-size-27mm. Based on FDA recall #Z-0136-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0136-2027%22&limit=1).
Why it’s dangerous
The catheter's sleeve liner may separate during use, preventing proper deployment of the heart valve device. This could lead to complications during the procedure or after implantation.
Who’s affected
Patients who received the recalled catheter for heart valve procedures are affected. Those with heart valve devices implanted via this catheter are at risk.
How to tell if you have this one
Check for the product name 'JenaValve Trilogy Delivery Catheter', size 27MM, and the reference code TRILOGY-DC-L. The lot numbers include DS-040926-004 through DS-060526-007.
- Brand
Jenavalve- Product
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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 number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0134-2027 | JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S; GTIN - 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 | 111 units |
| Z-0135-2027 | JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M; GTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001 | 108 units |
| Z-0136-2027 | JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L; 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 | 143 units |
What to do — step by step
Check Product Details
Identify the product name, size, and reference code to confirm if your catheter is recalled.
Contact Manufacturer
Reach out to Jenavalve Technology for specific guidance on next steps for your catheter.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 18 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Illinois, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
What are the lot numbers for the recalled product?
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.
Where was this product sold?
US Nationwide in states including AZ, CA, FL, GA, IL, MA, MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and countries including Germany, Denmark, Great Britain, Italy.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0136-2027 (July 31, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0136-2027 to see it in context.
- Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.