Nitinol TC Reusable Electrodes — Class II medical device recall Z-0687-2018
Terminated recall by Cosman Medical, LLC, reported 2018-02-28, distributed nationwide. After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs
| Recall number | Z-0687-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cosman Medical, LLC, Burlington, MA, United States |
| Recall initiated | 2017-07-05 |
| Classified | 2018-02-22 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2018-09-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Lot numbers | 4717, 4745, 4746, 4747, 4851, 4852, 4853, 4854, 4901, 4916, 4917, 4918, 5060, 5061, 5062, 5077, 5193, 5194, 5195, 5196, 5197, 5198, 5199, 5372, 5373, 5374, 5375, 5376, 5377, 5557, 5558, 6111, 6112, 6627, 6740, 6741, 6746, 6747, 6748, 6819 and 317 more |
| Model numbers | TCN-10, TCN-10-3M, TCN-15, TCN-15-3M, TCN-20, TCN-5, TCN-5-3M |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0687-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.