• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ReEntry" Malecot Nephrostomy Catheter Set

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall ReEntry" Malecot Nephrostomy Catheter Set see related information
Date Initiated by Firm December 12, 2017
Create Date March 18, 2018
Recall Status1 Terminated 3 on October 24, 2019
Recall Number Z-1103-2018
Recall Event ID 79424
Product Classification Catheter, nephrostomy, general & plastic surgery - Product Code GBO
Product Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268

The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
Code Information Expiration Date Range: 1/14/2018 - 10/9/2021; Batch: 16661359 18712075 20198264 16749367 18773340 20312730 16806828 18833032 20350212 16861193 18876338 20425132 17108329 18932471 20491746 17184858 19066695 20517722 17207012 19157075 20624080 17226842 19235547 20653111 17263721 19389756 20703430 17303885 19468061 20740699 17624941 19515681 20769253 17642196 19596299 20884299 17785597 19879546 20942364 17858548 19962558 20968667 17960226 19992214 20995564 18095912 20017161 21046941 18196369 20065717 21071138 18220028 20119217 21157954 18351957 20169832 21241250 18484526
Recalling Firm/
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Donna M. Gardner
Manufacturer Reason
for Recall
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm, Boston Scientific, sent an "Urgent Medical Device Product Removal - Immediate Action Required" letter dated 12/12/2017 to its consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to: identify and remove all affected batches from your inventory; immediately discontinue use of and segregate the affected product, and return it to Boston Scientific. Distributors were notified that this removal is to the customer level and asked to notify any customers who received affected product. Consignees were asked to complete and return the Replay Verification Tracking Form (even if you do not have any product to return) via email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center at 1-866-213-1806. If you have any questions, your local Sales Representative can answer any questions that you may have regarding this removal or contact Vice President , Regulatory Affairs at 508-683-4398 or email: Donna.Gardner@bsci.com or BSCFieldActionCenter@bsci.com.
Quantity in Commerce 2614
Distribution Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.
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.