FDA DeviceClass IINotable
FDA Recall: Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in);
Description
Reusable electrodes may not meet expected performance levels.
Hazard
Reusable electrodes may not meet expected performance levels.
Remedy
49,251 units
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