FDA Device recall Z-0665-2021
IceRod" 1.5 i-Thaw" 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 i-Thaw" 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-0665-2021 |
| 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 i-Thaw" Cryoablation Needle
Reason
Complaint trend regarding needle shaft gas leaks.
Identifiers
| code_info | UPN: FPRPR4009 UDIs: 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 72901…UPN: FPRPR4009 UDIs: 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204 Batch Numbers: U1362, U1217, U0957, U0283, U0282, U0087, T0819, T0392, A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, A1329 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0665-2021%22
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