FDA Device recall Z-0693-2021
IceRod" He-Thaw Prostate Cryoablation Kit
- FDA Device
- Class II
- completed
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of IceRod" He-Thaw Prostate Cryoablation Kit by Boston Scientific, citing complaint trend regarding needle shaft gas leaks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0693-2021 |
| 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" He-Thaw Prostate Cryoablation Kit
Reason
Complaint trend regarding needle shaft gas leaks.
Identifiers
| code_info | UPN: FPRPR4570 UDIs: 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105, 72901…UPN: FPRPR4570 UDIs: 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099 Batch Numbers:G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411 |
|---|
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-0693-2021%22
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