Recall Z-2679-2020 ยท GEH Unit, Cryosurgical, Accessories
Boston Scientific Corporation
Ablation Galil Technology, IcePearl2.1 CX ProstateKit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
| Date | Jun 4, 2020 |
| Status | Terminated |
| Reason | The needle surface deteriorated due to unexpected electrolysis during procedure. |
| Root cause | Nonconforming Material/Component |
| Action | Boston Scientific sent a letter dated 06/04/2020 and titled, "Urgent Medical Device Removal - Immediate Action Required" to customers regarding the IceFORCE 2.1 CX and IcePearl 2.1 CX Cryoablation Needles. The firm initiated a removal of specific lots/batches of IceFORCE 2.1 CX and IcePearl 2.1 CX Cryoablation Needles. The letter states that further distribution or use of any remaining product affected by the removal should cease immediately. Customers should verify the product lot/batch number to identify whether any product within their inventory is affected. If they have affected produ |
| Quantity | 193 devices |
| Distribution | Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoab Galil Medical , Ltd., Aug 28, 2015 |