The Recall Desk
ModerateFDA (Devices)·Z-2403-2026·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall describing an unquantified performance shortfall with no failure mode or clinical consequence stated, which fits the precautionary Moderate band.

Plain-English summary

Boston Scientific TCN Electrodes are being recalled, covering REF TCN-5, TCN-10, TCN-15 and TCN-20 nitinol electrodes measuring 5, 10, 15 and 20 cm by 0.45 mm, and their 3M variants. The action covers 49,251 units across all lots.

The stated reason is that the reusable electrodes may not meet expected performance levels. The FDA classified the action as Class II. The source does not describe a specific failure mode or clinical consequence.

Distribution was worldwide, including nationwide in the United States and to Peru, Mexico, Puerto Rico, Colombia, Malaysia and Canada. The electrodes are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the REF numbers and UDI codes in the recall notice and follow the instructions issued by Boston Scientific Neuromodulation.

The recalled product

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
Manufacturer
Boston Scientific Neuromodulation Corporation
Category
Medical Device — Electrode
Hazard
Affected units
49,251

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • All Lots: / UDI: TCN-10: 00813250013054
  • TCN-10-3M: 00813250017502
  • TCN-15: 00813250013061
  • TCN-15-3M: 00813250017519
  • TCN-20: 00813250013078
  • TCN-20-3M: 00813250017526
  • TCN-5: 00813250013047
  • TCN-5-3M:00813250017533

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Boston Scientific Neuromodulation Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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