{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Maple Grove", "address_1": "1 Scimed Pl", "reason_for_recall": "Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing potential for undesired blood leakage.", "address_2": "", "product_quantity": "29,169 units total", "code_info": "15611295 15624432 15653185 15657827 15675111 15640386 15679748 15684667 15698742 15716330 15736494 15736689 15746782 15711284 15753133 15757057 15760114 15764019 15767450 15768507 15770114 15772280 16635566 16691146 17148680 17628922 16675497 16723382 16731675 16738582 16740109 16752661 16760782 16880335 16897923 16904754 16751834 16893570 16894795 16933430 16937185 16940509 16943256 17038874 17041892 17044130 17046074 17123055 17126755 17127496 17133735 17138028 17206369 17210088 17211902 17214752 17218900 17296059 17300015 17388374 17388375 17388376 17388377 17453643 17453644 17708567 17708568 17708569 17708570 18014966 18014967 18014968 18075932 18075933 18075934 18075935 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Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, White Russia.", "state": "MN", "product_description": "Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.", "report_date": "20150923", "classification": "Class II", "openfda": {}, "recalling_firm": "Boston Scientific Corporation", "recall_number": "Z-2766-2015", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "72045", "termination_date": "20170404", "more_code_info": "", "recall_initiation_date": "20150825", "postal_code": "55311-1565", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }