Recall Z-1355-2015 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
| Date | Mar 31, 2015 (initiated Feb 25, 2015) |
| Status | Terminated |
| Reason | Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to retrieve the device fragments. |
| Root cause | Device Design |
| Action | Boston Scientific sent an Urgent Medical Device Correction - Immediate Action Required letter dated February 5, 2015. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter described the problem and the product involved in the recall. Advised consignees to complete and return the "Recall Removal Reply Verification Tracking Form". Your local Sales Representative can answer any questions you may have regarding this Field Correction notice. For further questions please call (763) 494- 7971. |
| Quantity | 289 |
| Distribution | Worldwide Distribution - US Distribution to the states of : CA, WI, FL and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland, Austria, Hungary, Netherlands and Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141335 | EXPEL APD DRAINAGE CATHETER SYSTEM Boston Scientific Corp, Oct 17, 2014 |