Recall Z-0687-2021 ยท GEH Unit, Cryosurgical, Accessories
Boston Scientific Corporation
IceSeed" Prostate Cryoablation Kit
| 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 | 52 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010991 | SEEDNET, MODELS FP6T5, FP5T5, FP5T3 Galil Medical , Ltd., May 3, 2001 |