Drug recall
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
FDA recall event 79529 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 79529 |
|---|---|
| Recall numbers | Z-1133-2018 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding. |
| Initiation date | Dec 20, 2017 |
| Report date | Mar 28, 2018 |
| Termination date | Dec 13, 2019 |
| 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: