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Class IIOngoing

Jenavalve Technology Inc. recalls 3 products

Recall date · record updated Oct 21, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Jenavalve Technology Inc.
Reason
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99697…

Products (3)

  1. JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S

    Codes/lots: 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-050726-005Quantity: 111 unitsRecall no. Z-0134-2027Class II

  2. JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M

    Codes/lots: GTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001Quantity: 108 unitsRecall no. Z-0135-2027Class II

  3. JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L

    Codes/lots: 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-060526-007Quantity: 143 unitsRecall no. Z-0136-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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