{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Minneapolis",
      "address_1": "13355 10th Ave N",
      "reason_for_recall": "BridgePoint Medical Inc. is voluntarily recalling  Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089.     BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal.  In no case was there any reported adverse clinical event related to the problem.",
      "address_2": "Suite #110",
      "product_quantity": "95 (57 USA, 38 OUS)",
      "code_info": "Lots affected in US: BP20121440078,  BP20121560089  Lots affected OUS: BP20121510086, BP20121500080",
      "center_classification_date": "20120724",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) including: AL, AZ, CA, CO, GA, IL, KY, MD, MN, MO, NC, NY, OR, PA, WA, and WI; and countries of: Australia and Sweden.",
      "state": "MN",
      "product_description": "BridgePoint Medical, Stingray  Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441.    Stingray\" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .",
      "report_date": "20120801",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Bridgepoint Medical",
      "recall_number": "Z-2074-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62450",
      "termination_date": "20120906",
      "more_code_info": "",
      "recall_initiation_date": "20120626",
      "postal_code": "55441-5553",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}