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U.S. Department of Health and Human Services

Class 2 Device Recall Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and BiliaryDrainage Catheter Kit

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  Class 2 Device Recall Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and BiliaryDrainage Catheter Kit see related information
Date Initiated by Firm February 25, 2015
Date Posted March 31, 2015
Recall Status1 Terminated 3 on June 30, 2017
Recall Number Z-1355-2015
Recall Event ID 70604
510(K)Number K141335  
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Code Information 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
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Brent Hathcock
763-494-7971
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP.
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