Boston Scientific Neuromodulation Corporation: 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.

Hazard

Reusable electrodes may not meet expected performance levels.

Details from the source

Reason for recall: Reusable electrodes may not meet expected performance levels. Distribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA. Quantity: 49,251 units Lot/code info: 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

UPC codes

00813250013054, 00813250017502, 00813250013061, 00813250017519, 00813250013078, 00813250017526, 00813250013047, 00813250017533

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.