FDA Device recall Z-0687-2018
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-15-3…
- FDA Device
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of 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-15-3… by Cosman Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0687-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-05 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cosman Medical |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | All TCN electrodes with model numbers below. Cat # TCN-10 Lot # 4717 4745 4851 4852 4916 5061 5193 5196 53…All TCN electrodes with model numbers below. Cat # TCN-10 Lot # 4717 4745 4851 4852 4916 5061 5193 5196 5372 5375 6111 6112 6627 6740 6746 6747 6819 6925 7525 7526 7806 8294 8422 8583 8942 9148 9327 9373 9374 9574 9978 A041 A143 A415 A435 A785 A797 B060 B061 B202 B264 B437 B814 B815 B901 B902 B903 C526 C527 C834 C846 D025 D157 D158 D238 D239 D602 D656 D685 D686 D946 D947 E129 E360 E382 E409 E410 E583 E714 E718 E886 E974 F074 F086 F101 F104 F112 F113 F178 F227 F228 F365 F366 F367 F368 F427 F428 F429 F555 F708 F709 F710 F711 F790 F791 F887 F888 F889 G007 G008 G116 G118 G119 G120 G152 G170 G171 G172 G352 G963 H011 H012 H016 H088 H089 H284 H347 H487 H488 H507 H595 H850 H872 H932 I011 I012 I056 I057 I145 I146 I236 I237 I246 I247 I294 I400 I401 I402 I448 I449 I450 I451 I547 I548 I580 I616 I617 I841 I842 I918 I919 I959 J008 J102 J180 J |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0687-2018%22
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