{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Fairfield",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92527",
      "recalling_firm": "Datascope Corp.",
      "address_1": "15 Law Dr Unit 1",
      "address_2": "N/A",
      "postal_code": "07004-3206",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Domestic distribution nationwide. International distribution worldwide.",
      "recall_number": "Z-2219-2023",
      "product_description": "MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES \t                                               D684-00-0295-01  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)\t                                         D684-00-0295-02  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (W/O STATLOCK)\t                      D684-00-0295-03  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA)\t                                   D684-00-0295-05  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES AND APA (CHINA)\t                D684-00-0295-06  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA\t          D684-00-0295-07  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK (APA) - INDIA  D684-00-0295-08  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\t                                   D684-00-0295-09  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) (TURKEY)\t                      D684-00-0295-10  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY\t                                   D684-00-0295-01U  MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA, US ONLY\t                             D684-00-0295-02U  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES\t                                                      D684-00-0294-01  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA)\t                                         D684-00-0294-02  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (W/O STATLOCK)\t                      D684-00-0294-03  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (CHINA)\t                                   D684-00-0294-05  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES AND APA (CHINA)\t                D684-00-0294-06  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA\t          D684-00-0294-07  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK (APA)   INDIA  D684-00-0294-08  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (TURKEY)\t                                   D684-00-0294-09  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) (TURKEY)\t                       D684-00-0294-10  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES, US ONLY\t                                   D684-00-0294-01U  MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA, US ONLY\t                             D684-00-0294-02U  PACKAGED INSERTION KIT - MEGA 7.5 Fr. 30/40 cc IABs                               D884-00-0019-21",
      "product_quantity": "321,609 total kits",
      "reason_for_recall": "During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath.  Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.",
      "recall_initiation_date": "20230623",
      "center_classification_date": "20230721",
      "report_date": "20230802",
      "code_info": "Product Description                                                    UDI MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES  10607567107974 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) 10607567107981 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (W/O STATLOCK) 10607567109404 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109039 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES AND APA (CHINA) 10607567109046 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA 10607567111339 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK (APA) - INDIA 10607567111346 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113241 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) (TURKEY) 10607567113258 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10605767109596 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA, US ONLY 10605767109602 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES 10607567107950 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) 10607567107967 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (W/O STATLOCK) 10607567109398 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (CHINA) 10607567109015 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES AND APA (CHINA) 10607567109022 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA 10607567111315 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK (APA)   INDIA 10607567111322 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (TURKEY) 10607567113227 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) (TURKEY) 10607567113234 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES, US ONLY 10607567109572 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA, US ONLY 10607567109589 PACKAGED INSERTION KIT - MEGA 7.5 Fr. 30/40 cc IABs 10607567108025"
    }
  ]
}