{"recall":{"id":"fda-device-99697","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Jenavalve Technology Inc. recalls 3 products","firm":"Jenavalve Technology Inc.","date":"2026-07-31","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S","code":"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","quantity":"111 units","number":"Z-0134-2027","classification":"Class II"},{"name":"JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M","code":"GTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001","quantity":"108 units","number":"Z-0135-2027","classification":"Class II"},{"name":"JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L","code":"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","quantity":"143 units","number":"Z-0136-2027","classification":"Class II"}],"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).","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.","nationwide":true,"states":[],"units":"111 units; 108 units; 143 units","remedy":"","whatToDo":"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.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99697","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"ccfbb109a32357fb","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99697","record":[{"status":"Ongoing","city":"Irvine","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99697","recalling_firm":"Jenavalve Technology Inc.","address_1":"4 Cromwell","address_2":"","postal_code":"92618-1816","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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":"Z-0134-2027","product_description":"JenaValve Trilogy Delivery Catheter, Size 23MM  REF: TRILOGY-DC-S","product_quantity":"111 units","reason_for_recall":"Delivery Catheter may  have sleeve liner separation that results in difficulty or inability  to  deploy heart valve device.","recall_initiation_date":"20260731","center_classification_date":"20261009","report_date":"20261021","code_info":"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","more_code_info":""},{"status":"Ongoing","city":"Irvine","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99697","recalling_firm":"Jenavalve Technology Inc.","address_1":"4 Cromwell","address_2":"","postal_code":"92618-1816","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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":"Z-0135-2027","product_description":"JenaValve Trilogy Delivery Catheter, Size 25MM  REF: TRILOGY-DC-M","product_quantity":"108 units","reason_for_recall":"Delivery Catheter may  have sleeve liner separation that results in difficulty or inability  to  deploy heart valve device.","recall_initiation_date":"20260731","center_classification_date":"20261009","report_date":"20261021","code_info":"GTIN - 00850000898141/Lot # DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005, DS-051526-001","more_code_info":""},{"status":"Ongoing","city":"Irvine","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99697","recalling_firm":"Jenavalve Technology Inc.","address_1":"4 Cromwell","address_2":"","postal_code":"92618-1816","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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":"Z-0136-2027","product_description":"JenaValve Trilogy Delivery Catheter, Size 27MM  REF: TRILOGY-DC-L","product_quantity":"143 units","reason_for_recall":"Delivery Catheter may  have sleeve liner separation that results in difficulty or inability  to  deploy heart valve device.","recall_initiation_date":"20260731","center_classification_date":"20261009","report_date":"20261021","code_info":"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","more_code_info":""}]}}