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U.S. Department of Health and Human Services

Class 2 Device Recall Pathway Balloon Expandable Ureteral Access Sheath 13/16/36

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  Class 2 Device Recall Pathway Balloon Expandable Ureteral Access Sheath 13/16/36 see related information
Date Initiated by Firm November 30, 2007
Date Posted April 30, 2008
Recall Status1 Terminated 3 on October 22, 2008
Recall Number Z-0909-2008
Recall Event ID 46330
510(K)Number K061009  
Product Classification Ureteral dilator - Product Code EZN
Product Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Code Information Lot numbers: W03-1482, W03-1491, W03-1508, W03-1524, W03-1740, W03-1917, W03-2107, W03-2113, W03-2214, W03-2216, W03-2236, W03-2239, W03-2240, W03-2285, W03-2354, W03-2410, W03-2446, W03-2457, W03-2483, W03-2580
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
500 Commander Shea Blvd
Quincy MA 02171-1518
For Additional Information Contact Robert T. Miragliuolo
508-683-4186
Manufacturer Reason
for Recall		 Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
FDA Determined
Cause 2		 Device Design
Action Consignees were sent an Urgent Medical Device Recall letter on November 29, 2007. The letter instructed users to check their inventory, remove any affected product and place them in quarantine. It also included instructions for returning the product. Users were asked to return a Reply Verification Tracking Form. Follow-up communication will be made to users who do not return the tracking form.
Quantity in Commerce 325
Distribution Nationwide Distribution
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 = EZN and Original Applicant = ONSET MEDICAL CORPORATION
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