TheraSphere Administration Set — Class II medical device recall Z-2328-2021
Ongoing recall by Boston Scientific Corporation, reported 2021-08-25, distributed nationwide. Potential for leaks and loosening at the patient catheter connection
| Recall number | Z-2328-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2021-07-23 |
| Classified | 2021-08-19 |
| Reported by FDA | 2021-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, CA, CH, DE, ES, FR, GB, HK, IE, IL, IN, IT, NL, PL, PT, SA, SG, TR |
| Quantity | 4,200 sets |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 05060116920635 |
| Lot numbers | 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61705933, 61706656, 61732176 |
| Model numbers | OTT-SPE-FP-001 |
Product
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Reason for recall
Potential for leaks and loosening at the patient catheter connection
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-2328-2021. 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.