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U.S. Department of Health and Human Services

Class 2 Device Recall Spyscope DS Access and Delivery Catheter

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  Class 2 Device Recall Spyscope DS Access and Delivery Catheter see related information
Date Initiated by Firm December 20, 2017
Create Date March 19, 2018
Recall Status1 Terminated 3 on December 13, 2019
Recall Number Z-1133-2018
Recall Event ID 79529
510(K)Number K142922  
Product Classification Choledochoscope and accessories, flexible/rigid - Product Code FBN
Product SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Code Information 21071349 21186199 21264281 21338493 21072506 21186874 21264826 21339969 21097205 21189216 21268628 21346857 21099913 21192332 21269880 21348369 21101809 21194784 21275009 21348655 21104860 21196427 21279183 21351508 21106212 21196815 21280166 21354138 21111667 21197475 21282419 21355128 21112353 21198355 21284302 21356067 21120166 21201164 21285174 21359495 21121467 21203598 21285708 21360857 21125598 21204762 21287283 21361914 21129863 21207916 21291325 21366469 21134585 21210287 21291903 21368941 21136699 21212151 21295990 21372468 21139834 21215249 21301969 21373463 21143014 21216252 21302617 21373946 21 150144 21218379 21305351 21377827 21150932 21220903 21307321 21380698 21156170 21221247 21308963 21381638 21159396 21226282 21310860 21385327 211 60496 21227147 21311361 21387164 21163684 21233949 21313025 21387745 2 1164861 21235402 21313392 21391319 21165772 21237929 21315518 21393249 211 68729 21240546 21316968 21393900 21169977 21241587 21317017 21395015 21170814 21245984 21322828 21395016 21174026 21246770 21324197 21401047 211 75845 21249893 21324851 21401048 211 76842 21251968 21329021 21401049 21180343 21253001 21329708 21413940 21181253 21254244 21332229 21414750 21181677 21257214 21334848 21420240 21186002 21260915 21335787
Recalling Firm/
Manufacturer
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Jennifer Kimball
508-683-4178
Manufacturer Reason
for Recall
Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
FDA Determined
Cause 2
Process design
Action The notification letter requests the consignee to identify and return the affected product along with the response form. Distributors are asked to share the recall information to the customer level. 12/20/2017 by mail.
Quantity in Commerce 5026
Distribution Worldwide Distribution US nationwide, Austria, Belarus, Belguim, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Bahrain, China, Hong Kong, India, Malaysia, Pakistan, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Thailand, Tunisia, Turkey, Vietnam, Brazil, Canada, Cost Rica, Ecuador, Guatemala, Mexico, Peru
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 = FBN and Original Applicant = BOSTON SCIENTIFIC CORPORATION
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