Boston Scientific Neuromodulation Corporation: Probe, Radiofrequency Lesion
Recall Summary Boston Scientific is recalling TCN Electrodes (in sizes 5cm, 10cm, 15cm, and 20cm) used in radiofrequency lesion procedures because they may not perform as expected. The affected products were distributed nationwide in the US and in several other countries including Canada, Mexico, Peru, and Colombia. This is a Class II recall affecting medical devices that may have been used in patient treatments.
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- 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 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...
- Reason
- Reusable electrodes may not meet expected performance levels.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6d03e53a-079b-45f9-9052-a4e997049dbd