Nitinol TC Reusable Electrodes (TCN)
Medical device recall Z-0687-2018. Published in FDA’s Enforcement Report on Feb 28, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 28, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 11250 units (10,460 USA; 790 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
11250 units (10,460 USA; 790 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,939 characters
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 J181 J306 J307 J308 J560 J561 J680 J808 J810 J811 J958 J959 K165 Cat # TCN-10-3M Lot # B463 B612 C711 D430 D781 E414 E508 E618 E972 F426 F523 F604 F788 G075 G383 G413 G611 G761 G764 G826 G968 H085 H093 H286 H324 H345 H496 H582 H614 H735 I013 I578 I619 I751 J511 J515 J563 J682 J730 Cat # TCN-15 Lot # 4746 4854 4901 4917 5060 5194 5197 5373 5376 5557 6741 6820 7227 8295 8943 9165 9386 9575 A078 A416 A434 B062 B438 B904 C060 C212 C285 C845 D240 D241 D603 D950 E133 E381 E411 E584 E715 E970 F072 F183 F229 F369 F396 F430 F431 F712 F713 F789 F890 F891 G000 G169 G440 G943 G952 H004 H090 H285 H508 H594 H608 I399 I409 I452 I453 I549 I579 I615 I843 I920 I960 J101 J182 J310 J562 J681 J812 J813 J960 J961 Cat # TCN-15-3M Lot # B613 C707 E509 F714 G168 H094 H287 H325 H346 I752 J564 Cat # TCN-20 Lot # H091 J183 5077 5199 5558 6821 6832 6924 8944 9576 Cat # TCN-5 Lot # A417 A786 B439 C528 D242 D687 D945 E130 E625 E887 F076 F201 F230 G266 G762 H015 H092 H619 I144 I618 J100 J184 J309 J731 4747 4853 4918 5062 5195 5198 5374 5377 6748 6822 7640 8945 9577 Cat # TCN-5-3M Lot # B614 D024 F946 G076 H095 J886
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (nationwide) and country of Canada.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 5, 2017.
- FDA classified it on Feb 22, 2018.
- FDA’s Enforcement Report published it on Feb 28, 2018.
- FDA terminated it on Sep 14, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cosman Medical, LLC, of Burlington, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.