FDA Device recall Z-0679-2021
IceRod" 1.5 MRI Cryoablation Needle¿
- FDA Device
- Class II
- completed
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of IceRod" 1.5 MRI Cryoablation Needle¿ by Boston Scientific, citing complaint trend regarding needle shaft gas leaks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0679-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-11-18 |
| Published | 2020-12-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
IceRod" 1.5 MRI Cryoablation Needle¿
Reason
Complaint trend regarding needle shaft gas leaks.
Identifiers
| code_info | UPN: FPRPR3193 UDIs: 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 72901…UPN: FPRPR3193 UDIs: 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273 Batch Numbers: U1440, U1441, U1311, U1312, U1015, U1016, U0462, U0461, U0050, U0030, T0520, T0521, T0157, T0158, A7135, A7134, A6987, A6986, A6707, A6708, A6689, A6688, A1730, A1731, A1149, A1150 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0679-2021%22
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