{ "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": "16752208 16891755 17138030 17211903 17214753 17296669 17395755 17483898 17712231 18053939 18120336 F00541702 F00541703 F00541707 F00541708 F00541709 F00541903 F00541904 F00541905 F00541906 F00541907 F00541908 F00541909 F00541913 F00541914 F00541916 F00544503 F00544504 F00544505 F00544508 F00544509 F00544511 F00544703 F00544704 F00544706 F00544707 F00544709 F00544710 F00545201 F00547501 F00547502 F00547505 F00547506 F00547507 F00547508 F00547509 F00547510 F00547511 F00547512 F00547514 F00548202 F00548204 F00548205 F00548206 F00548207 F00548210 F00548211 F00548213 F00548215 15513009 15556842 15559607 15559608 15573287 15576411 15579547 15583022 15586521 15597796 15608021 15634208 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18153571 18280015", "center_classification_date": "20150915", "distribution_pattern": "Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, White Russia.", "state": "MN", "product_description": "Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use.", "report_date": "20150923", "classification": "Class II", "openfda": {}, "recalling_firm": "Boston Scientific Corporation", "recall_number": "Z-2765-2015", "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" } ] }