Recall Z-0658-2021 ยท GEH Unit, Cryosurgical, Accessories
Boston Scientific Corporation
IceFORCE" 2.1 CX Cryoablation Needle
| Date | Nov 18, 2020 |
| Status | Completed |
| Reason | Complaint trend regarding needle shaft gas leaks. |
| Root cause | Under Investigation by firm |
| Action | Customers will be sent a product advisory via overnight mail. |
| Quantity | 75 units |
| Distribution | Nationwide |
| 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 |