Date Initiated by Firm |
May 17, 2010 |
Date Posted |
June 25, 2010 |
Recall Status1 |
Terminated 3 on October 20, 2011 |
Recall Number |
Z-1870-2010 |
Recall Event ID |
55784 |
510(K)Number |
K032930
|
Product Classification |
Prosthesis, esophageal - Product Code ESW
|
Product |
Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/10/7. Catalog Number M00514200. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
|
Code Information |
Lot Numbers: 11724987 11724988 11734435 11737583 11748771 11748772 11756570 11783350 11784125 11784126 11788500 11788503 11789459 11789742 11791144 11812880 11838269 11839624 11839625 11846978 11862055 11862180 11864139 11864324 11872977 11873066 11881271 11881274 11897035 11897036 11897037 11899692 11899698 11931126 11933274 11933275 11946248 11946258 11948987 11948996 11964769 11964770 11967548 11967553 11977090 11977095 11978680 11978685 11992342 11992546 12000584 12009401 12015328 12015330 12019592 12028945 12028946 12072518 12072702 12075379 12075447 12087138 12088069 12088079 12088429 12095741 12095742 12120601 12120607 12133899 12134066 12145573 12146922 12155699 12156122 12160344 12165839 12178975 12179041 12182459 12182821 12197976 12206065 12208161 12217860 12225458 12225459 12226308 12226309 12241286 12241291 12267605 12273755 12302865 12302866 12323320 12373984 12378799 12401568 12404304 12408206 12425916 12440785 12492053 12509060 12520229 12527380 12545466 12559352 12563316 12588686 12779710 12868020 12873723 12913911 12946192 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234
|
For Additional Information Contact |
same 508-683-8000
|
Manufacturer Reason for Recall |
Suture related device failures during deployment and repositioning of the stent
|
FDA Determined Cause 2 |
Device Design |
Action |
Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form.
For further information, contact Boston Scientific at 1-866-868-4004. |
Distribution |
Worldwide Distribution - Only US distributed product is affected by recall |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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510(K) Database |
510(K)s with Product Code = ESW and Original Applicant = BOSTON SCIENTIFIC CORP.
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