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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Stonetome Stone Removal Device

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  Class 2 Device Recall Boston Scientific Stonetome Stone Removal Device see related information
Date Initiated by Firm January 08, 2009
Date Posted March 11, 2009
Recall Status1 Terminated 3 on October 22, 2009
Recall Number Z-1012-2009
Recall Event ID 50861
510(K)Number K946358  
Product Classification Dislodger, stone, biliary - Product Code LQR
Product Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm, 5.5 Fr, 20 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3515.

The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
Code Information Lot Numbers: 11988198 and 11989069.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
866-868-4004
Manufacturer Reason
for Recall		 The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
FDA Determined
Cause 2		 Packaging
Action Consignees were notified via letter dated January 8, 2009 to discontinue use of the affected product and to return it to Boston Scientific. Customers were instructed to complete and fax the Reply Verification Tracking Form to Boston Scientific at 508-683-5578. Direct questions about this recall to your local Sales Representative.
Quantity in Commerce 294 of all products.
Distribution Nationwide.
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 = LQR and Original Applicant = BOSTON SCIENTIFIC CORP.
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