Recall Z-0666-2021 ยท GEH Unit, Cryosurgical, Accessories
Boston Scientific Corporation
IceRod" 1.5 PLUS 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 | 4,645 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110946 | ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE Galil Medical , Ltd., Jun 21, 2011 |