The Recall Desk

FDA (Devices) recall action 85085

Boston Scientific Neuromodulation Corporation recalled 5 products on 2020-04-22

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
2020-04-22
Critical
0
Units
748

Why these products were recalled

The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.

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)··2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 43 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Distribution
    24 states
  • LowFDA (Devices)··2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 110 Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Distribution
    24 states
  • ModerateFDA (Devices)··2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 118 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Distribution
    24 states
  • LowFDA (Devices)··2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 437 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Distribution
    24 states
  • ModerateFDA (Devices)··2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 40 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Distribution
    24 states