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U.S. Department of Health and Human Services

Class 2 Device Recall NephroMax high Pressure nephrostomy Balloon Catheter Kit.

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  Class 2 Device Recall NephroMax high Pressure nephrostomy Balloon Catheter Kit. see related information
Date Initiated by Firm May 28, 2013
Date Posted July 09, 2013
Recall Status1 Terminated 3 on January 23, 2014
Recall Number Z-1673-2013
Recall Event ID 65317
510(K)Number K121614  
Product Classification Cather, Nephrostomy - Product Code LJE
Product NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164

Dilation of the nephrostomy tract.
Code Information Lot Number: 15982017, 15963887, 16034014
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Kallie Iverson
763-494-1133
Manufacturer Reason
for Recall		 Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
FDA Determined
Cause 2		 Process control
Action The firm, Boston Scientific, sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated May 28, 2013, consignees via Federal Express Priority Mail to its consignees/customers.OUS - Customer notification letters has also been sent to consignees/customers in the EU. The letter instructs the customers to Immediately discontinue use of and segregate recalled product; check their inventory; immediately remove all affected product from their inventory, and return it to Boston Scientific at Boston Scientific Corporation, US Distribution Center, Customer Fulfillment Center, 500 Commander Shea Blvd., Quincy, Massachusetts 02171 include original Verification Tracking Form and RGA #. The letter also requests the completion and return of the Account Reply Verification Tracking Form via email to: MapleGroveFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806. Follow up communications will be made to the customers that do not respond to this inquiry. Distributors are instructed to forward the recall notification to their customers. If you have any questions call 763-494-1133 or email to MapleGroveFieldActionCenter@bsci.com.
Quantity in Commerce 15 units
Distribution Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.
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 = LJE and Original Applicant = BOSTON SCIENTIFIC CORP.
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