Recall Z-0671-2021 ยท GEH Unit, Cryosurgical, Accessories
Boston Scientific Corporation
IceSphere" 1.5 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 | 245 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141485 | ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE Galil Medical , Ltd., Jul 2, 2014 |