Cosman Medical Recalls

Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M, 12) TCNK-20-C, 13) TCN-5, 14) TCNK-20-R, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCNK-10-C & 20) TCNK-5-R. The TCN devices are indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only.

Class I - Dangerous

After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.

Jul 5, 2017 Other Medical Devices Nationwide View Details →