{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "179611", "product_res_number": "Z-1555-2020", "event_date_initiated": "2020-02-11", "event_date_posted": "2020-03-25", "recall_status": "Open, Classified", "res_event_number": "84886", "product_code": "DQO", "k_numbers": [ "K121694" ], "product_description": "Imager II 5F Angiographic Catheters, 5 units per package.", "code_info": "All lots of the following: 1\tMaterial Number (UPN) Outer Package\tM001314041,\tMaterial Number (UPN) Inner Package\tM001314040 2\tMaterial Number (UPN) Outer Package\tM001314051,\tMaterial Number (UPN) Inner Package\tM001314050 3\tMaterial Number (UPN) Outer Package\tM001314061,\tMaterial Number (UPN) Inner Package\tM001314060 4\tMaterial Number (UPN) Outer 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Number (UPN) Inner Package\tM001314860 73\tMaterial Number (UPN) Outer Package\tM001314871,\tMaterial Number (UPN) Inner Package\tM001314870 74\tMaterial Number (UPN) Outer Package\tM001314881,\tMaterial Number (UPN) Inner Package\tM001314880 75\tMaterial Number (UPN) Outer Package\tM001314891,\tMaterial Number (UPN) Inner Package\tM001314890 76\tMaterial Number (UPN) Outer Package\tM001314901,\tMaterial Number (UPN) Inner Package\tM001314900 77\tMaterial Number (UPN) Outer Package\tM001314911,\tMaterial Number (UPN) Inner Package\tM001314910 78\tMaterial Number (UPN) Outer Package\tM001315031,\tMaterial Number (UPN) Inner Package\tM001315030 79\tMaterial Number (UPN) Outer Package\tM001315051,\tMaterial Number (UPN) Inner Package\tM001315050 80\tMaterial Number (UPN) Outer Package\tM001315061,\tMaterial Number (UPN) Inner Package\tM001315060 81\tMaterial Number (UPN) Outer Package\tM001315071,\tMaterial Number (UPN) Inner Package\tM001315070 82\tMaterial Number (UPN) Outer Package\tM001315081,\tMaterial Number (UPN) Inner Package\tM001315080 83\tMaterial Number (UPN) Outer Package\tM001315131,\tMaterial Number (UPN) Inner Package\tM001315130 84\tMaterial Number (UPN) Outer Package\tM001315141,\tMaterial Number (UPN) Inner Package\tM001315140 85\tMaterial Number (UPN) Outer Package\tM001315151,\tMaterial Number (UPN) Inner Package\tM001315150 86\tMaterial Number (UPN) Outer Package\tM001315191,\tMaterial Number (UPN) Inner Package\tM001315190 87\tMaterial Number (UPN) Outer Package\tM001315211,\tMaterial Number (UPN) Inner Package\tM001315210 88\tMaterial Number (UPN) Outer Package\tM001315231,\tMaterial Number (UPN) Inner Package\tM001315230 89\tMaterial Number (UPN) Outer Package\tM001315281,\tMaterial Number (UPN) Inner Package\tM001315280 90\tMaterial Number (UPN) Outer Package\tM001315291,\tMaterial Number (UPN) Inner Package\tM001315290 91\tMaterial Number (UPN) Outer Package\tM001315301,\tMaterial Number (UPN) Inner Package\tM001315300 92\tMaterial Number (UPN) Outer Package\tM001315311,\tMaterial Number (UPN) Inner Package\tM001315310 93\tMaterial Number (UPN) Outer Package\tM001315321,\tMaterial Number (UPN) Inner Package\tM001315320 94\tMaterial Number (UPN) Outer Package\tM001315331,\tMaterial Number (UPN) Inner Package\tM001315330  **** UPDATE: The firm expanded this recall to include ALL lots/batches of the 5F curved tip shapes of the Imager II Angiographic Catheters on 08/05/2020. This update is posted in RES on 10/05/2020.", "firm_fei_number": "3002095335", "recalling_firm": "Boston Scientific Corporation", "address_1": "1 Scimed Pl", "city": "Maple Grove", "state": "MN", "postal_code": "55311-1565", "additional_info_contact": "Nicole Pshon\n763-494-1133", "reason_for_recall": "Potential for tip detachment of Imager II 5F Angiographic Catheters", "root_cause_description": "Environmental control", "action": "Boston Scientific notified customers on about 02/11/2020 via \"Urgent Medical Device Removal\" letter. Customers were informed that Boston Scientific has noticed an increase in the rate of tip detachment complaints involving the recalled devices. \n\nInstructions included to examine inventory and quarantine affected products, complete and return the Verification Form, return all affected devices to Boston Scientific, and notify customers if affected devices were further distributed.\n\nAn expansion letter was dated 08/06/2020 to include all batches/lots of the BSC Imager II Angiographic Catheter - 5 French Curved Tip Shapes.", "product_quantity": "1068827 Single Units", "distribution_pattern": "Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa.", "openfda": { "k_number": [ "K781558", "K952773", "K936282", "K882796", "K894401", "K111619", "K000825", "K885348", "K897051", "K930081", "K862030", "K842798", "K760388", "K003902", "K231293", "K935654", "K063784", "K915726", "K180846", "K915836", "K042685", "K141769", "K934581", "K950440", "K921649", "K922105", "K904618", "K173762", "K180054", "K242966", "K862673", "K061963", "K913364", "K943192", "K870419", "K170544", "K920870", "K822290", "K032624", "K905625", "K852197", "K930232", "K101625", "K131437", "K905297", "K984627", "K934541", "K803270", "K920407", "K864141", "K061733", "K965112", "K230620", "K010707", "K870700", 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