Five IceSphere" Prostate Cryoablation Kit — Class II medical device recall Z-0689-2021
Completed recall by Boston Scientific Corporation, reported 2020-12-30, distributed nationwide. Complaint trend regarding needle shaft gas leaks.
| Recall number | Z-0689-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2020-11-18 |
| Classified | 2020-12-22 |
| Reported by FDA | 2020-12-30 |
| Distributed | Nationwide (US) |
| Quantity | 419 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07290104830969 |
| Lot numbers | A1184, A1382, A1577, A1607, A1626, A1629, A2088, A2101, A6737, A6789, A6890, A6952, A6953, A7009, T0103, T0104, T0127, T0362, T0363, T0373, T0374, T0461, T0462, T0483, T0484, T0635, T0672, T0673, U0122, U0154, U0155, U0183, U0216, U0384, U0389, U0402, U0407, U0411, U0470, U0823 and 13 more |
Product
Five IceSphere" Prostate Cryoablation Kit
Reason for recall
Complaint trend regarding needle shaft gas leaks.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0689-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.