Recall Z-0687-2018 ยท GXI Probe, Radiofrequency Lesion
Cosman Medical, LLC
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 lesionin
| Date | Jul 5, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | The firm, Cosman Medical, sent an "Urgent Medical Device Correction" notice and Field Correction Reply Verification Tracking Form dated July 5, 2017 to their customers. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following: 1. Immediately discontinue use of devices that have already been used. Used TCN Electrodes should be disposed of in accordance with your institutions infectious material/biohazard waste control procedures. 2. Unused/un-opened TCN Electrodes should be identified as single use only (for one patient). These devices |
| Quantity | 11250 units (10,460 USA; 790 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050084 | COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; Cosman Medical, Inc., Mar 17, 2005 |