FDA Device recall Z-2327-2021
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
- FDA Device
- Class II
- ongoing
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) by Boston Scientific, citing potential for leaks and loosening at the patient catheter connection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2327-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-23 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Reason
Potential for leaks and loosening at the patient catheter connection
Identifiers
| code_info | GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2327-2021%22
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