{ "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": "180253", "product_res_number": "Z-1567-2020", "event_date_initiated": "2020-03-23", "event_date_posted": "2020-04-01", "recall_status": "Open, Classified", "res_event_number": "85193", "product_code": "DXE", "k_numbers": [ "K022145" ], "product_description": "LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88.\n\nThe LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.", "code_info": "OTW2897¿ OTW3273¿ OTW3333¿ OTW3379¿ OTW3418¿ OTW3543¿ OTW3564¿ OTW3620¿ OTW3700¿ OTW3740¿ OTW3758¿ OTW3805¿ OTW3865¿ OTW3879¿ OTW3892¿ OTW3966¿ OTW4009¿ OTW4010¿ OTW4017¿ OTW4018¿ OTW4024¿ OTW4060¿ OTW4063¿ OTW4064¿ OTW4065¿ OTW4117¿ OTW4201¿ OTW4238¿ OTW4239¿ OTW2957¿ OTW3001¿ OTW3266¿ OTW3395¿ OTW3565¿ OTW3637¿ OTW3638¿ OTW3658¿ OTW3665¿ OTW3670¿ OTW3671¿ OTW3682¿ OTW3683¿ OTW3694¿ OTW3695¿ OTW3701¿ OTW3708¿ OTW3727¿ OTW3728¿ OTW3747¿ OTW3769¿ OTW3770¿ OTW3775¿ OTW3776¿ OTW3779¿ OTW3780¿ OTW3810¿ OTW3820¿ OTW3821¿ OTW3853¿ OTW3854¿ OTW3880¿ OTW3881¿ OTW3886¿ OTW3893¿ OTW3898¿ OTW3899¿ OTW3915¿ OTW3916¿ OTW3924¿ OTW3930¿ OTW3957¿ OTW3958¿ OTW3981¿ OTW3982¿ OTW4011¿ OTW4025¿ OTW4026¿ OTW4030¿ OTW4031¿ OTW4052¿ OTW4053¿ OTW4054¿ OTW4066¿ OTW4067¿ OTW4068¿ OTW4073¿ OTW4074¿ OTW4075¿ OTW4092¿ OTW4093¿ OTW4098¿ OTW4099¿ OTW4105¿ OTW4106¿ OTW4107¿ OTW4119¿ OTW4120¿ OTW4157¿ OTW4158¿ OTW4188¿ OTW4197¿ OTW4220¿ OTW4221¿ OTW4222¿ OTW4229¿ OTW4230¿ OTW4247¿ OTW4249¿ OTW4254¿ OTW4255¿ OTW4258¿ OTW4259¿ OTW4260¿ OTW4261¿ OTW4263¿ OTW4291¿ OTW4294¿ OTW4339¿ OTW4341¿ OTW4363¿ OTW4364¿ OTW2942¿ OTW2959¿ OTW2987¿ OTW3207¿ OTW3292¿ OTW3303¿ OTW3312¿ OTW3322¿ OTW3323¿ OTW3351¿ OTW3367¿ OTW3438A¿ OTW3511¿ OTW3635¿ OTW3636¿ OTW3660¿ OTW3661¿ OTW3667¿ OTW3688¿ OTW3689¿ OTW3706¿ OTW3707¿ OTW3711¿ OTW3717¿ OTW3718¿ OTW3734¿ OTW3750¿ OTW3783¿ OTW3784¿ OTW3794¿ OTW3795¿ OTW3827¿ OTW3828¿ OTW3851¿ OTW3852¿ OTW3862¿ OTW3863¿ OTW3882¿ OTW3896¿ OTW3897¿ OTW3907¿ OTW3908¿ OTW3931¿ OTW3936¿ OTW3944¿ OTW3945¿ OTW3962¿ OTW3963¿ OTW3978¿ OTW3979¿ OTW3995¿ OTW3996¿ OTW4033¿ OTW4034¿ OTW4057¿ OTW4058¿ OTW4084¿ OTW4085¿ OTW4127¿ OTW4128¿ OTW4140¿ OTW4141¿ OTW4146¿ OTW4147¿ OTW4176¿ OTW4177¿ OTW4183¿ OTW4184¿ OTW4191¿ OTW4192¿ OTW4193¿ OTW4232¿ OTW4317¿ OTW4336¿ OTW2872¿ OTW3191¿ OTW3439¿ OTW3537¿ OTW3623¿ OTW3662¿ OTW3668¿ OTW3669¿ OTW3690¿ OTW3691¿ OTW3712¿ OTW3735¿ OTW3766¿ OTW3771¿ OTW3812¿ OTW3822¿ OTW3823¿ OTW3836¿ OTW3849¿ OTW3850¿ OTW3874¿ OTW3888¿ OTW3903¿ OTW3925¿ OTW3932¿ OTW3946¿ OTW3947¿ OTW3968¿ OTW3969¿ OTW3987¿ OTW3988¿ OTW4020¿ OTW4021¿ OTW4036¿ OTW4037¿ OTW4038¿ OTW4079¿ OTW4080¿ OTW4087¿ OTW4196¿ OTW4267¿ OTW4268¿ OTW4269¿ OTW4270¿ OTW4275¿ OTW4276¿ OTW4277¿ OTW4288¿  ***Added 3/19/20*** OTW2847¿ OTW2863¿ OTW2871¿  ***Updated 4/14/20*** The firm noted upon review that some of the original recall lots were originally relabeled with different lot numbers for Non-US customers. Those additional lot numbers are as follow:  OTW3461 OTW3501 OTW3591 OTW3628 OTW3737 OTW3742 OTW3753 OTW3813 OTW3859 OTW3861 OTW4208  ***Updated 8/21/20***  Lots OTW4180, OTW4187, OTW4198, OTW4202, OTW4218, OTW4246", "firm_fei_number": "1220948", "recalling_firm": "LeMaitre Vascular, Inc.", "address_1": "63 2nd Ave", "city": "Burlington", "state": "MA", "postal_code": "01803-4413", "additional_info_contact": "Laurie Churchill\n781-425-1670", "reason_for_recall": "There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.", "root_cause_description": "Process control", "action": "On March 23, 2020, the firm distributed \"URGENT: MEDICAL DEVICE RECALL\" letters to affected customers. Customers were notified of the risk of the catheter failing to deflate, which may ultimately lead to tip separation.\n\nCustomers were asked to do the following:\n\n1. Check your inventory and immediately quarantine any recalled devices.\n2. Complete the form at the end of this letter. Please note that you must return the form even if you have no devices in inventory.\n3. Scan the reply form and send it to recalls@lemaitre.com.\n4. If you have recalled devices at your facility, LeMaitre Vascular, Inc. will send you instructions for returning the devices.\n5. When the recalled devices have been received by LeMaitre Vascular, we will arrange for replacement material.\n6. If you have transferred devices to another facility, please forward a copy of this recall letter to them.\n\nCustomers with questions may contact the Senior Quality Engineer, at rlerer@lemaitre.com or 781-221-2266.\n\n***Updated 8/21/20***\n\nFirm added Lots OTW4180, OTW4187, OTW4198, OTW4202, OTW4218, OTW4246 to the recall. These lots were previously on hold in a warehouse in Germany, but in July they were mistakenly distributed to customers in Europe.", "product_quantity": "43315", "distribution_pattern": "Worldwide distribution: US (Nationwide distribution) and foreign countries of: Australia, Austria, Belgium, Bulgaria, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Georgia, Hungary, Ireland, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.", "openfda": { "k_number": [ "K002627", "K992934", "K213771", "K973465", "K901625", "K910372", "K901502", "K891021", "K901627", "K152335", "K900311", "K820646", "K770569", "K892410", "K780762", "K961992", "K022145", "K955125", "K163031", "K972572", "K954760", "K240078", "K970762", "K972511", "K897184", "K202049", "K974335", "K241330", "K935405", "K163353", "K920823", "K883852", "K872485", "K893680", "K973477", "K864062", "K100840", "K850015", "K853625", "K982141", "K992933", "K832023", "K864330", "K961883", "K801650", "K961716", "K902327", "K100842", "K920871", "K081573", "K233619", "K905139", "K972623", "K812640", "K780244", "K020634", "K832044", "K992940", "K770714", "K233819", "K233820", "K011783", "K950586", "K894681", "K864007", "K992368", "K971314", "K761031", "K970657", "K881455", "K914880", "K193379", "K790838", "K840198" ], "registration_number": [ "3015225571", "3011137372", "3030714660", "2029386", "2648045", "3045042524", "2015691", "1061124", "3006950086", "1820334", "9680794", "3005704822", "3012536737", "8043983", "9617465", "3033589330", "3040153768", "3009051888", "1319639", "9615817", "1220452", "2183744", "2183870", "3035111606", "1000393132", "3013666218", "3008496528", "3012050423", "1721686", "3015309643", "3006082230", "2522007", "3032916632", "1220948", "1018233", "3010041511", "2024311", "2027111", "9616662", "1724474", "3015859709", "1721504" ], "fei_number": [ "3015225571", "3030714660", "2648045", "3045042524", "2015691", "3005747797", "3006950086", "1820334", "3005704822", "3012536737", "3033589330", "3016261803", "3040153768", "3003769549", "1000306647", "3009051888", "3000335778", "1220452", "2183744", "3003081151", "2183870", "3035111606", "1000393132", "1000138054", "3013666218", "3003094851", "3008496528", "3012050423", "1721686", "3003737899", "3015309643", "3006082230", "2522007", "3032916632", "1220948", "1018233", "3010041511", "2024311", "2027111", "1000512168", "3015859709", "1721504" ], "device_name": "Catheter, Embolectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ] }