{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "86388", "product_res_number": "Z-0337-2010", "event_date_initiated": "2009-10-22", "event_date_posted": "2010-01-21", "recall_status": "Terminated", "event_date_terminated": "2011-12-12", "res_event_number": "53704", "product_code": "KOD", "k_numbers": [ "K011965" ], "product_description": "Imager\" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland:\nProduct Description and Material/UPN/Catalog Number\nImager\" II Catheters C2, 5Fr, 65cm\t M0064003010 (inner pouch)\n M0064003011 (outer box);\nImager\" II Catheters Straight, 5Fr, 65cm\tM0064003020 (inner pouch)\n M0064003021 (outer box) and\nImager\" II Catheters Bern, 5Fr, 65cm\tM0064003030 (inner pouch)\n M0064003031 (outer box)\n\nThe Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steal braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.", "code_info": "Lot/Batch No.  57271 57616 57269 and 57613.", "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": "763-494-1700", "reason_for_recall": "The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.", "root_cause_description": "Packaging process control", "action": "Two Boston Scientific \"Urgent Voluntary Medical Device Recall\" letters were sent to consignees on October 29, 2009. The letters described the problem and the affected product. Consignees were instructed to cease use and distribution of the product and to complete and return the Account Reply Verification Tracking Form. \n\nThe first letter with the heading, \"Boston Scientific IMAGER II Angiographic Catheter (Peripheral Intervention)\", was addressed to the Risk Manager/Field Action Contact. The second letter with the heading, \"Imager II Urology Torque Catheters\" was addressed to the Risk/Materials Manager. Direct questions about the recall to your local Sales Representative or Boston Scientific Corporation by calling at 1-763-494-1700.", "product_quantity": "74 boxes (5/box) US; 18 boxes (5/box) OUS", "distribution_pattern": "Worldwide Distribution -- United States (AL, AZ, AR, CA, CO,CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VT, VA, WA, WV and WI), United Arab Emir., Dutch Antilles, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Israel, Italy, South Korea, Kuwait, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, New Zealand, Poland, Puerto Rico, Portugal, Qatar, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, and South Africa.", "openfda": { "k_number": [ 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"3006430057", "3004605321", "1000317571", "1313046", "3013517171", "9611004" ], "fei_number": [ "3004727093", "2936999", "3008307705", "3005012805", "1000393132", "3018094310", "3002558692", "3003040625", "3004784537", "3010400865", "3007185216", "3002807099", "3003898360", "3008816891", "3015173212", "3009337401", "1000160458", "3007134520", "2523865", "3015895045", "1825146", "3014656749", "3008191244", "7682", "3006082230", "3003172243", "3002808327", "3002807170", "3006174295", "3013530345", "1721676", "3006279007", "1000121056", "3003076831", "3003565456", "3010220595", "3004111573", "3005674464", "3007007790", "1000306139", "3014195785", "3003903031", "3001236905", "3002695476", "3013557562", "1220477", "2025851", "1043214", "3009609358", "1000112877", "2124215", "3002826093", "3011987967", "1000112968", "3002468371", "1820334", "3001124136", "3006582718", "3004970277", "3015453963", "3005778470", "3004365956", "2183744", "1417592", "3002806934", "1921846", "3002807574", "1048735", "3007829657", "3008824097", "1928237", "3002806591", "3005483737", "1480288", "1000115586", "3012421607", "3001436772", "3030447506", "2011171", "3006759904", "3013024191", "1721686", "3006017180", "3002806565", "3002807626", "3016863553", "3014579161", "1828132", "3005987240", "3002808269", "3005099803", "3030733800", "3002807391", "3009271244", "3010273872", "1000160215", "3006536657", "3008806809", "2828", "1018233", "3009504230", "3022518300", "1000237915", "3008502431", "3017171849", "3014404707", "3006430057", "3004605321", "1000317571", "1313046", "3003058448", "3005747797", "3013517171" ], "device_name": "Catheter, Urological", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5130", "device_class": "2" } } ] }