{"recall":{"id":"fda-device-99836","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter","firm":"LeMaitre Vascular, Inc.","date":"2026-08-28","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;","code":"Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;","quantity":"54","number":"Z-0117-2027","classification":"Class II"}],"reason":"Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.","nationwide":true,"states":[],"units":"54","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=99836","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5d74d84f46f43a2d","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=99836","record":[{"status":"Ongoing","city":"Burlington","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99836","recalling_firm":"LeMaitre Vascular, Inc.","address_1":"32 3rd Ave","address_2":"N/A","postal_code":"01803-4414","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.","recall_number":"Z-0117-2027","product_description":"TufTex¿ Over-the-Wire Embolectomy Catheter;  Catalog Number: E1651-88;","product_quantity":"54","reason_for_recall":"Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.","recall_initiation_date":"20260828","center_classification_date":"20261007","report_date":"20261014","code_info":"Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;"}]}}