The Recall Desk

FDA (Devices) recall action 98939

Boston Scientific Neuromodulation Corporation recalled 2 products on 2026-06-17

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
2026-06-17
Critical
0
Units
81,174

Why these products were recalled

Reusable electrodes may not meet expected performance levels.

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

  • ModerateFDA (Devices)··2026-06-17

    Boston Scientific reusable TCN nitinol electrodes may underperform expected levels

    Boston Scientific TCN nitinol electrodes across four lengths are being recalled because the reusable electrodes may not meet expected performance levels. 49,251 units affected.

    Product
    Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2026-06-17

    Boston Scientific reusable CSK stainless steel electrodes may underperform expected levels

    Boston Scientific CSK stainless steel electrodes across several lengths are being recalled because the reusable electrodes may not meet expected performance levels. 31,923 units affected.

    Product
    Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3
    Category
    Distribution
    3 states