Recall Z-1133-2018 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
Boston Scientific Corporation
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
| Date | Dec 20, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | The notification letter requests the consignee to identify and return the affected product along with the response form. Distributors are asked to share the recall information to the customer level. 12/20/2017 by mail. |
| Quantity | 5026 |
| Distribution | Worldwide Distribution US nationwide, Austria, Belarus, Belguim, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Bahrain, China, Hong Kong, India, Malaysia, Pakist |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142922 | SpyGlass DS Direct Visualization System Boston Scientific Corporation, Jan 16, 2015 |