Recall Z-0680-2021 ยท GEH Unit, Cryosurgical, Accessories
Boston Scientific Corporation
IceSeed" 1.5 MRI 90 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 | 1,526 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051052 | SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) Galil Medical , Ltd., May 6, 2005 |