Manufacturers

Cosman Medical, LLC

  • Adresse du fabricant
    Cosman Medical, LLC, 22 Terry Ave, Burlington MA 01803-2516
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA
  • 1 Event

Un dispositif médical dans la base de données

Device Recall Nitinol TC Reusable Electrodes (TCN)
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and country of Canada.
  • Description du dispositif
    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.