The Recall Desk

FDA (Devices) recall action 84375

Boston Scientific Corporation recalled 2 products on 2019-12-18

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-12-18
Critical
0
Units
318

Why these products were recalled

During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.

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

1–2 of 2

  • HighFDA (Devices)··2019-12-18

    Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk

    Boston Scientific is recalling 139 Habib EUS RFA electrode tips because capacitive coupling may cause thermal injury to tissue outside the target area.

    Product
    Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2019-12-18

    Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk

    Boston Scientific is recalling 179 Habib EUS RFA electrode tips because capacitive coupling may cause unintended thermal injury to tissue outside the treatment area.

    Product
    Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
    Category
    Distribution
    13 states