Drug recall
Contour VL Ureteral Stent Set 6FX22-30CM with.035 Sensor UPN: M006180156080
FDA recall event 85227 · Class II · Boston Scientific
Key facts
| Event ID | 85227 |
|---|---|
| Recall numbers | Z-1729-2020, Z-1730-2020, Z-1731-2020, Z-1732-2020, Z-1733-2020, Z-1734-2020, Z-1735-2020, Z-1736-2020, Z-1737-2020, Z-1738-2020, Z-1739-2020, Z-1740-2020 |
| Recalling firm | Boston Scientific |
| Product type | Devices |
| Products | Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080, Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110, Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110, Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021), Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 and 7 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
| Initiation date | Mar 9, 2020 |
| Report date | Apr 29, 2020 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 3009695231 |
At a glance
- 10–99 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: