{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183757", "product_res_number": "Z-0181-2021", "event_date_initiated": "2020-08-24", "event_date_created": "2020-10-22", "recall_status": "Terminated", "event_date_terminated": "2024-04-05", "res_event_number": "86466", "product_code": "OBJ", "k_numbers": [ "K200733" ], "product_description": "Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021\nMaterial Number (UPN) # H7493932800350\nUDI # 08714729984542\nLot #25754545; 25852104; 2582106; 25856700\nProduct Usage: intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.", "code_info": "Opticross 35 15 MHz Peripheral Imaging Catheter  8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700", "firm_fei_number": "3001451463", "recalling_firm": "Boston Scientific Corporation", "address_1": "500 Commander Shea Blvd", "city": "Quincy", "state": "MA", "postal_code": "02171-1518", "additional_info_contact": "Nicole Pshon\n763-494-1133", "reason_for_recall": "Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. \n\nThe most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter.\n\nAll recalled devices should be returned to Boston Scientific.", "root_cause_description": "Process control", "action": "All affected customers were sent a letter on 08/24/2020 stating the following: Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. \n\nThe most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter.\n\nAll recalled devices should be returned to Boston Scientific.", "product_quantity": "41 devices", "distribution_pattern": "US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA.", "openfda": { "k_number": [ "K251231", "K160583", "K141618", "K213593", "K080891", "K200812", "K193183", "K081625", "K233270", "K200195", "K251211", "K153617", "K160514", "K222568", "K092596", "K173820", "K103255", "K252945", "K250955", "K241540", "K123813", "K152829", "K170992", "K170263", "K253399", "K132133", "K212959", "K230453", "K261849", "K050995", "K250913", "K201775", "K163478", "K041727", "K200410", "K240050", "K091352", "K123621", "K242893", "K033650", "K223766", "K071660", "K111043", "K122878", "K172258", "K223077", "K113008", "K191175", "K120697", "K071554", "K041134", "K143701", "K173618", "K133853", "K051679", "K203726", "K073473", "K103260", "K173284", "K233948", "K031346", "K081626", "K071234", "K101138", "K161125", "K140318", "K081808", "K051337", "K153094", "K173063", "K260816", "K030524", "K112050", "K150442", "K251103", "K092064", "K121273", "K042593", "K070242" ], "registration_number": [ "3013403214", "3010432890", "3033527283", "2134243", "1058584", "2029275", "3012179728", "9617277", "3008497357", "2518586", "2124215", "3011610434", "3019216", "8010026", "3012833053", "3016678045", "3003594449", "3009077524", "3033527241", "9612283", "3010952312", "2011171", "2024311", "1225687", "2030404", "1721686", "2032112", "3003898360", "9680579", "9610482", "8043817", "3014272734", "3031397684", "3007738736", "3009350690", "3011416394", "3013734919", "3003493679", "2090040", "3015276088", "3010041511", "3005467144", "3012127758", "2134265", "3032109181", "3014745562", "9673241", "3010398867", "3012198618", "3006985147", "3000126629", "9710602", "3005334138", "1000601180", "3008452825", "3007695959", "3017060084", "9681834", "3023245", "3008496839", "3009196578", "2032350", "2531814", "2182269", "3008363989", "3038966633", "3015551113", "3016171942", "1061124", "3008516548", "3017894900", "3017461134", "3005877899", "3015859709", "3002619337", "3019807891", "3011763071", "3009888344", "3035950510", "3033508292", "3013844297", "3032807464", "3005403518", "3013162291", "1928237", "3009537152", "3010273872", "3016076141", "2030624", "9680794", "3013944123", "3011137372", "3005012805", "2939520", "3013300026", "3009490946", "3038718997" ], "fei_number": [ "3013403214", "3010432890", "3033527283", "1000219637", "3005747797", "3002626007", "3012179728", "3001451463", "1000203464", "3008497357", "2518586", "2124215", "2828", "3011610434", "3019216", "3012833053", "3002808327", "3003513129", "3016678045", "3003594449", "3003248396", "3000206435", "1000519796", "3009077524", "3033527241", "3003190524", "3003309342", "3010952312", "2011171", "3003076831", "2024311", "1721686", "3003898360", "1000306431", "3014272734", "3031397684", "3001726808", "3007738736", "3009350690", "3011416394", "3013734919", "3003493679", "3015276088", "3010041511", "3005467144", "3012127758", "3032109181", "3014745562", "3010398867", "3012198618", "3006985147", "3000126629", "3005334138", "1000601180", "3002095335", "3008452825", "3007695959", "3017060084", "3023245", "3008496839", "3009196578", "3003737899", "1000512168", "2182269", "3008363989", "3038966633", "3015551113", "3016171942", "3008516548", "3017894900", "3017461134", "3005877899", "3015859709", "3002619337", "3002808529", "3019807891", "3011763071", "3009888344", "3035950510", "3033508292", "3013844297", "3032807464", "3003094575", "3005403518", "3013162291", "1928237", "3009537152", "3002808457", "3010273872", "3016076141", "3013944123", "3005012805", "2939520", "3002615969", "3013300026", "3009490946", "3038718997" ], "device_name": "Catheter, Ultrasound, Intravascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1200", "device_class": "2" } } ] }