FDA Device recall Z-0671-2021
IceSphere" 1.5 Cryoablation Needle
- FDA Device
- Class II
- completed
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of IceSphere" 1.5 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-0671-2021 |
| 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
IceSphere" 1.5 Cryoablation Needle
Reason
Complaint trend regarding needle shaft gas leaks.
Identifiers
| code_info | UPN: FPRPR3558 UDIs: 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 72901…UPN: FPRPR3558 UDIs: 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938 Batch numbers: U1403, U1218, U0295, U0215, U0182, U0153, U0047, T0674, T0463, T0129, A7010, A6956, A6893, A6738, A2102, A1185 |
|---|
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-0671-2021%22
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