{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "105171", "product_res_number": "Z-0264-2012", "event_date_initiated": "2011-11-03", "event_date_posted": "2011-11-21", "recall_status": "Terminated", "event_date_terminated": "2013-01-15", "res_event_number": "60365", "product_code": "DRE", "k_numbers": [ "K052557" ], "product_description": "Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA.\n\nSuper Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9.\n\n\nSuper Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8.\n\n\nSuper Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6.\n\nThe device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.", "code_info": "11B15B6 11B23B7 11B28B9 11C09BA 11C16B9 11C30B9 11C07B8 11B01B4 11B25B6", "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": "Boston Scientific is initiating a medical device recall removal regarding nine lots/batches of Super Sheath and Super Sheath R/O Introducer Sheaths. Boston Scientific was informed through product complaints that the 0.035\" ID dilator may be labeled incorrectly as a 0.038\" ID dilator.", "root_cause_description": "Packaging process control", "action": "Boston Scientific sent an URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED letter dated November 21, 2011. The letter described the product and the problem. Customers were instructed to segregate the affected product immediately and return it to Boston Scientific. Distributors were advised that the recall removal depth is to the hospital level and the recall removal notification should be forwarded to their customers.\n\nFor questions regarding this recall call 763-494-1133.", "product_quantity": "2660", "distribution_pattern": "Worldwide Distribution - USA including AZ, AR, CA, CO, FL, GA, IL, KY, LA, MD, MA, MN, MO, NE, NJ, NM, NY, OH, OK PA, RI, TN, TX, UT, VA, WY, WI, and WV and the countries of BELGIUM, BRAZIL, CZECH REPUBLIC, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, ITALY, NETHERLANDS, RUSSIAN FEDERATION, SOUTH KOREA, SPAIN, SWEDEN, and UKRAINE.", "openfda": { "k_number": [ "K871148", "K141148", "K010055", "K212784", "K161333", "K073035", "K875327", "K130791", "K211679", "K161336", "K140047", "K980282", "K913027", "K030260", "K052557", "K840017", "K904476", "K843261", "K902469", "K840671", "K963388", "K251325", "K081940", "K200379", "K842113", "K872724", "K182064", "K800462", "K000737", "K242229", "K970470", "K831190", "K870413", "K874738", "K210734", "K061000", "K190175", "K151877", "K142301", "K970392", "K882238", "K261310", "K031691", "K162389", "K141070", "K082075", "K253616", "K150932", "K813461", "K070749", "K862288", "K223472", "K192195", "K123445", "K162181", "K050962", "K132713", "K151076", "K894330", "K192283", "K760403", "K833965", "K201288", "K905416", "K103421", "K960917", "K241720", "K914555", "K071330", "K012256", "K813125", "K091584", "K150360", "K070159", "K233647", "K120349", "K822595", "K062554", "K810859", "K896096", "K901815", "K170616", "K123842", "K801113", "K945586", "K840022", "K850337", "K141131", "K172487", "K802327", "K881073", "K232609", "K142546", "K912050", "K183036", "K182914", "K974617", "K023507", "K841995", "K133631", "K974640", "K092378", "K860161", "K780126", "K093554" ], "registration_number": [ "", "3006283319", "3019751610", "1828424", "9610849", "3005334138", "3009211636", "2648727", "3003637635", "1054241", "1724474", "3013666336", "2030624", "1722746", "2528981", "3007695959", "3030447506", "3011468686", "1928237", "9680841", "3004111573", "1319211", "8043892", "3002807314", "1721676", "1282497", "2011171", "3031571797", "2124215", "2032228", "3033589330", "3007146453", "1000393132", "3011642792", "1644312", "1721686", "3011623145", "3007882731", "3011657089", "3032916632", "2182208", "9612126", "3019807891", "3015309643", "1123137", "9616099", "3000126629", "3003915875", "1000523114", "3012536737", "3014656749", "1000121056", "3010273872", "1625425", "3010665433", "3030714660", "1043214", "1643817", "3005580113", "3030446844", "3004784537", "2527072", "3025341484", "1718850", "2183744", "2246552", "1721504", "3006082230", "2522007", "3006950086", "3030574705", "9616662", "2029275", "3009888344", "3018565086", "3027260597", "2032521", "3038188187", "3036802499", "1055236", "3012453745", "1649395", "9681477", "3005941719", "3008423561", "1018233", "2953359", "1016427", "3007284006", "9616683", "1319639", "2518902", "3015225571", "3020778", "9610139", "9611665", "1820334", "2648045", "8010762" ], "fei_number": [ "", "3006283319", "3003528016", "3019751610", "1828424", "3005334138", "3009211636", "2648727", "3002807439", "3003637635", "3013666336", "1000306431", "2528981", "3007695959", "1000117748", "3030447506", "3002807095", "3011468686", "1928237", "3004111573", "1319211", "3002807314", "1000138054", "3005426550", "1721676", "1282497", "2011171", "3003166981", "3031571797", "2124215", "3033589330", "3007146453", "1000393132", "3011642792", "1721686", "3011623145", "3007882731", "3011657089", "3032916632", "2182208", "3019807891", "3015309643", "1000112877", "3000126629", "3003094851", "3003915875", "3002807548", "1000523114", "3012536737", "3002807391", "1000306216", "3014656749", "1000121056", "3010273872", "1625425", "3010665433", "3030714660", "1043214", "3003574398", "1643817", "3005580113", "3030446844", "3004784537", "2527072", "3025341484", "1718850", "2183744", "2246552", "1721504", "3002808050", "3006082230", "2522007", "3002806500", "3006950086", "3030574705", "3009888344", "3018565086", "3027260597", "3000335778", "3038188187", "3036802499", "1000123180", "1000112968", "3012453745", "3008423561", "1018233", "3000718472", "3009649876", "3002807111", "1016427", "3007284006", "2518902", "3015225571", "3020778", "3000215205", "3004970277", "1820334", "2648045", "3000206435" ], "device_name": "Dilator, Vessel, For Percutaneous Catheterization", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1310", "device_class": "2" } } ] }