Drug recall
Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
FDA recall event 86880 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 86880 |
|---|---|
| Recall numbers | Z-0757-2021, Z-0758-2021 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190, Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel. |
| Initiation date | Nov 16, 2020 |
| Report date | Jan 6, 2021 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 3005099803 |
At a glance
- 1–9 Products in this recall
- None 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: