—#134146

Product

Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K141335
Affected lot / code info: UPN # LOT # H7493933108200 17245003, 17416605, 17489192 H7493933108350 17245004, 17245005, 17370709, 17408756 H749393310835K1 17411333, 17493554 H7493933110200 17318047 H7493933110350 17275822, 17438003, 17494025, 17501572 H749393311035K1 17328808, 17403871, 17416578, 17459144 H7493933110400 17275824, 17416608 H7493933112350 17245006, 17259580, 17275819 H7493933114350 17275815, 17338207 with Expiration Dates between January 30, 2016 and May 8, 2016

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-02-25
Posted by FDA: 2015-03-31
Terminated: 2017-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134146. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.