The Recall Desk

FDA (Devices) recall action 78323

Boston Scientific Corporation recalled 5 products on 2017-11-15

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2017-11-15
Critical
0
Units
36

Why these products were recalled

The devices have an incorrect firmware configuration.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2017-11-15

    Boston Scientific Recalls Four VIGILANT X4 CRT-D Devices for Firmware Error

    Boston Scientific is recalling four VIGILANT X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications…
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2017-11-15

    Boston Scientific Recalls 12 Resonate EL ICD Devices for Firmware Error

    Boston Scientific is recalling 12 Resonate EL ICD DR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    RESONATE EL ICD DR, Model D433, Sterile.
    Category
    Distribution
    2 states