{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Burlington",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85193",
      "recalling_firm": "LeMaitre Vascular, Inc.",
      "address_1": "63 2nd Ave",
      "address_2": "N/A",
      "postal_code": "01803-4413",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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.",
      "recall_number": "Z-1567-2020",
      "product_description": "LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88.    The 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.",
      "product_quantity": "43315",
      "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.",
      "recall_initiation_date": "20200323",
      "center_classification_date": "20200401",
      "report_date": "20200408",
      "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"
    }
  ]
}