Drug recall
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
FDA recall event 88369 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 88369 |
|---|---|
| Recall numbers | Z-2327-2021, Z-2328-2021 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE), TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for leaks and loosening at the patient catheter connection |
| Initiation date | Jul 23, 2021 |
| Report date | Aug 25, 2021 |
| City | Maple Grove |
| State | MN |
| Country | United States |
| FEI number | 3002095335 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: