IceSeed" 1 — Class II medical device recall Z-0680-2021
Completed recall by Boston Scientific Corporation, reported 2020-12-30, distributed nationwide. Complaint trend regarding needle shaft gas leaks.
| Recall number | Z-0680-2021 |
|---|---|
| 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 | 1,526 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07290104830280 |
| Lot numbers | A0954, A0955, A1007, A1008, A1040, A1041, A1196, A1197, A1325, A1326, A1533, A1562, A1563, A1690, A1844, A1845, A1890, A1891, A1990, A1991, A1998, A1999, A2049, A2050, A6697, A6698, A6719, A6720, T0262, T0263, T0353, T0354, T0442, T0443, T0444, T0530, T0531, T0532, T0533, U0241 and 8 more |
Product
IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿
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-0680-2021. 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.