{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "country": "United States",
      "city": "Fremont",
      "address_1": "48501 Warm Springs Blvd Ste 108",
      "reason_for_recall": "Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).",
      "address_2": "",
      "product_quantity": "612",
      "code_info": "Catalog No. Part No.                   Size                 Lot #       UDI (DI Portion Only)      S4IVL2540 FG61163-2540 2.50x40mm P180222I       M732S4IVL25400                                                                                  P180327A                                                                                  P180410A                                                                                  P180503A   S4IVL3040 FG61163-3040 3.00x40mm P180223A      M732S4IVL30400                                                                                  P180327B                                                                                  P180410B                                                                                  P180503B   S4IVL3540 FG61163-3540 3.50x40mm P180223B      M732S4IVL35400                                                                                  P180327C                                                                                  P180410C                                                                                  P180503C   S4IVL4040 FG61163-4040 4.00x40mm P180223C     M732S4IVL40400                                                                                  P180327D                                                                                  P180410D                                                                                  P180503D",
      "center_classification_date": "20180925",
      "distribution_pattern": "Domestic: CO, TN and TX  Foreign: Austria, Germany and New Zealand",
      "state": "CA",
      "product_description": "The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.  Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE 0086, STERILE R,  Manufacturer: Shockwave Medical, Inc. 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539",
      "report_date": "20181003",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Shockwave Medical, Inc.",
      "recall_number": "Z-3247-2018",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "80865",
      "termination_date": "20200122",
      "more_code_info": "",
      "recall_initiation_date": "20180718",
      "postal_code": "94539-7750",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}