CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

Boston Scientific TCN Electrodes recalled

Boston Scientific Neuromodulation is recalling Boston Scientific TCN Electrodes, distributed nationwide in the US. The recall was initiated on 29 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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

Quantity recalled49,251 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2403-2026
FDA event ID: 98939
Recalling firm: Boston Scientific Neuromodulation, Valencia, CA
Classification: Class II
Status: Ongoing
Recall initiated: 29 Apr 2026
FDA classified: 11 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

29 Apr 2026	Recall initiated by company
11 Jun 2026	Classified by FDA	+43 days
17 Jun 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reusable electrodes may not meet expected performance levels.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 mm (0.0175 in) REF: TCN-5-3m, TCN Electrode, NITINOL, 3M CABLE, 5 cm x 0.45 mm (0.0175 in) REF: TCN-10-3M, TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in); REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in) REF: TCN-20-3M, TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in)

Where it was distributed

Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.

Nationwide California Colorado Puerto Rico

Questions about this recall

Why was it recalled?

Reusable electrodes may not meet expected performance levels.

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98939

This product is part of a recall event; the main page for the event is Boston Scientific CSK Electrodes recalled.

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