Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70632
  • Event Risk Class
    Class 2
  • Event Number
    Z-1336-2015
  • Event Initiated Date
    2015-02-25
  • Event Date Posted
    2015-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134175
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, biliary, diagnostic - Product Code FGE
  • Reason
    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.
  • 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.

Device

Device Recall Boston Scientific: Expel Drainage Catheter with TwistLoc Hub APDL Drainage Cathete...
  • Model / Serial
    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.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    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.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA