{
  "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": "2026-10-13"
  },
  "results": [
    {
      "term": "Explanted",
      "count": 1213
    },
    {
      "term": "Other (for use when an appropriate device code cannot be identified)",
      "count": 946
    },
    {
      "term": "Program, failure to",
      "count": 536
    },
    {
      "term": "Replace",
      "count": 436
    },
    {
      "term": "Partial Blockage",
      "count": 342
    },
    {
      "term": "Break",
      "count": 272
    },
    {
      "term": "Programming Issue",
      "count": 271
    },
    {
      "term": "Occlusion Within Device",
      "count": 194
    },
    {
      "term": "Valve(s), failure of",
      "count": 189
    },
    {
      "term": "Obstruction of Flow",
      "count": 151
    },
    {
      "term": "Appropriate Device Problem Term/Code Not Available",
      "count": 150
    },
    {
      "term": "Pressure Problem",
      "count": 141
    },
    {
      "term": "Insufficient Device Problem Information",
      "count": 125
    },
    {
      "term": "Device Dislodged or Dislocated",
      "count": 110
    },
    {
      "term": "No Flow",
      "count": 110
    },
    {
      "term": "Device Issue",
      "count": 108
    },
    {
      "term": "Device Difficult to Program or Calibrate",
      "count": 100
    },
    {
      "term": "Restricted Flow rate",
      "count": 98
    },
    {
      "term": "Adverse Event Without Identified Device or Use Problem",
      "count": 94
    },
    {
      "term": "Leak/Splash",
      "count": 88
    },
    {
      "term": "Mechanical Problem",
      "count": 72
    },
    {
      "term": "Valve(s), defective",
      "count": 57
    },
    {
      "term": "Use of Device Problem",
      "count": 55
    },
    {
      "term": "Excess Flow or Over-Infusion",
      "count": 53
    },
    {
      "term": "Device Operational Issue",
      "count": 52
    },
    {
      "term": "Device remains implanted",
      "count": 41
    },
    {
      "term": "Material Separation",
      "count": 41
    },
    {
      "term": "Malfunction",
      "count": 40
    },
    {
      "term": "Insufficient Flow or Under Infusion",
      "count": 35
    },
    {
      "term": "Infusion or Flow Problem",
      "count": 34
    },
    {
      "term": "Improper Flow or Infusion",
      "count": 33
    },
    {
      "term": "Fluid/Blood Leak",
      "count": 30
    },
    {
      "term": "Migration or Expulsion of Device",
      "count": 29
    },
    {
      "term": "Tears, rips, holes in device, device material",
      "count": 29
    },
    {
      "term": "Detachment Of Device Component",
      "count": 28
    },
    {
      "term": "Output, high",
      "count": 28
    },
    {
      "term": "Component(s), broken",
      "count": 27
    },
    {
      "term": "Disconnection",
      "count": 27
    },
    {
      "term": "Crack",
      "count": 20
    },
    {
      "term": "Decrease in Pressure",
      "count": 19
    },
    {
      "term": "Output Problem",
      "count": 19
    },
    {
      "term": "Complete Blockage",
      "count": 18
    },
    {
      "term": "Valve(s), sticking",
      "count": 18
    },
    {
      "term": "Dislodged",
      "count": 17
    },
    {
      "term": "No Device Output",
      "count": 17
    },
    {
      "term": "Defective Device",
      "count": 16
    },
    {
      "term": "Self-Activation or Keying",
      "count": 16
    },
    {
      "term": "Device Operates Differently Than Expected",
      "count": 15
    },
    {
      "term": "Fracture",
      "count": 15
    },
    {
      "term": "Implant, removal of",
      "count": 14
    },
    {
      "term": "Overheating of Device",
      "count": 14
    },
    {
      "term": "Pressure, insufficient",
      "count": 14
    },
    {
      "term": "Sticking",
      "count": 14
    },
    {
      "term": "Electrical /Electronic Property Problem",
      "count": 13
    },
    {
      "term": "Increase in Pressure",
      "count": 12
    },
    {
      "term": "Unknown (for use when the device problem is not known)",
      "count": 12
    },
    {
      "term": "Device, removal of (non-implant)",
      "count": 11
    },
    {
      "term": "Inaccurate Flow Rate",
      "count": 11
    },
    {
      "term": "Source, detachment from",
      "count": 11
    },
    {
      "term": "Detachment of Device or Device Component",
      "count": 10
    },
    {
      "term": "Hole In Material",
      "count": 10
    },
    {
      "term": "Split",
      "count": 10
    },
    {
      "term": "Device, or device fragments remain in patient",
      "count": 9
    },
    {
      "term": "Pressure sensor failure",
      "count": 9
    },
    {
      "term": "Repair",
      "count": 9
    },
    {
      "term": "Failure to Align",
      "count": 8
    },
    {
      "term": "Foreign material",
      "count": 8
    },
    {
      "term": "Output, low",
      "count": 8
    },
    {
      "term": "Positioning Problem",
      "count": 8
    },
    {
      "term": "Separation Problem",
      "count": 8
    },
    {
      "term": "Torn Material",
      "count": 8
    },
    {
      "term": "Device Inoperable",
      "count": 7
    },
    {
      "term": "Noise",
      "count": 7
    },
    {
      "term": "Cut In Material",
      "count": 6
    },
    {
      "term": "Device Damaged Prior to Use",
      "count": 6
    },
    {
      "term": "Device Displays Incorrect Message",
      "count": 6
    },
    {
      "term": "Failure to Reset",
      "count": 6
    },
    {
      "term": "Flushing Problem",
      "count": 6
    },
    {
      "term": "Improper or Incorrect Procedure or Method",
      "count": 6
    },
    {
      "term": "Defective Component",
      "count": 5
    },
    {
      "term": "Device Contamination with Chemical or Other Material",
      "count": 5
    },
    {
      "term": "Excessive Heating",
      "count": 5
    },
    {
      "term": "Failure to Prime",
      "count": 5
    },
    {
      "term": "Incorrect, Inadequate or Imprecise Result or Readings",
      "count": 5
    },
    {
      "term": "Kinked",
      "count": 5
    },
    {
      "term": "Loose",
      "count": 5
    },
    {
      "term": "Migration",
      "count": 5
    },
    {
      "term": "Use of Incorrect Control/Treatment Settings",
      "count": 5
    },
    {
      "term": "Device Slipped",
      "count": 4
    },
    {
      "term": "Difficult To Position",
      "count": 4
    },
    {
      "term": "Failure to Deliver",
      "count": 4
    },
    {
      "term": "Failure to Pump",
      "count": 4
    },
    {
      "term": "Filling Problem",
      "count": 4
    },
    {
      "term": "Incorrect Measurement",
      "count": 4
    },
    {
      "term": "Incorrect Software Programming Calculations",
      "count": 4
    },
    {
      "term": "Material Puncture/Hole",
      "count": 4
    },
    {
      "term": "Material Rupture",
      "count": 4
    },
    {
      "term": "Microbial Contamination of Device",
      "count": 4
    },
    {
      "term": "Activation, Positioning or Separation Problem",
      "count": 3
    },
    {
      "term": "Air Leak",
      "count": 3
    }
  ]
}