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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific: Expel Drainage Catheter with TwistLoc Hub APDL Drainage Catheter and APDL Drai

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  Class 2 Device Recall Boston Scientific: Expel Drainage Catheter with TwistLoc Hub APDL Drainage Catheter and APDL Drai see related information
Date Initiated by Firm February 25, 2015
Date Posted March 27, 2015
Recall Status1 Terminated 3 on August 12, 2016
Recall Number Z-1336-2015
Recall Event ID 70632
510(K)Number K141335  
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.
Code Information UPN # LOT #  H7493931006200- 17259582, 17362835, 17501623, 17617274. H7493931008200- 17259557, 17297984, 17362834, 17376747. H7493931010200- 17318044, 17376748, 17459140, 17501573, 17617545.  H7493931012250- 17275816, 17501620, 17575123, 17617353. H7493931014250- 17370708, 17604432, 17624928. H7493931106150- 17259581, 17365684, 17617551. H7493931108150- 17244079, 17404400, 17408751, 17493552, 17647113 H7493931108250- 17245000, 17275820, 17297985, 17297986, 17377401, 17416602, 17433865.  H749393110825K1- 17416577. H7493931108450- 17245001, 17408755, 17411332, 17493550. H7493931110150- 17317825, 17518149. H7493931110250- 17228343, 17259558, 17317546, 17338203, 17365681, 17416573, 17438002, 17518150, 17588842, 17588844, 17621339, 17634403, 17634404, 17639037.  H749393111025K1- 17328810, 17403872, 17416575, 17494061. H7493931110450- 17275823, 17416603, 17459143, 17617552. H7493931112250- 17259584, 17275818, 17338205, 17365682, 17601584, 17613485, 17639463.  H7493931112450- 17245002, 17259556, 17365683, 17416604, 17574538, 17617553.  H7493931114250- 17370706, 17588840, 17625218. H7493931114450- 17275817, 17589950, 17624789. H7493932016300- 17328801, 17352479, 17377392, 17408752, 17501571, 17575124, 17612692, 17613484, 17625883, 17626180, 17626181, 17626182.  H7493932018300- 17377395, 17480649, 17614751, 17617350, 17626183. H7493932024400- 17459142, 17492863. H7493932026400- 17328800, 17353160, 17377393, 17617470, 17624927, 17625216, 17625895. 
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		 Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation after an Expel" APD catheter was implanted in the biliary system. The most serious foreseeable patient risk for this issue is additional intervention for fragment retrieval using minimally invasive meth
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Boston Scientific sent an "Urgent Medical Device Correction" letter dated February 25, 2015, to all affected customers. The letter described the problem and the product involved in the recall. The letter informed customers not to use the Expel APD and APDL Drainage catheters for bile drainage and to complete and return the Customer Acknowledgement Form. The letter also noted that the devices are not being retrieved and they are not required to return them to Boston Scientific. For further questions please call (763) 494-7971.
Quantity in Commerce 918
Distribution Worldwide Distribution - US Distribution to the states of : CA, LA, FL, WI, NY, IL, MD 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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