Class 2 Device Recall Malecot Nephrostomy Catheter Set

• Date Initiated by Firm: December 12, 2017
• Create Date: March 18, 2018
• Recall Status: Terminated on October 24, 2019
• Recall Number: Z-1100-2018
• Recall Event ID: 79424
• Product Classification: Catheter, nephrostomy, general & plastic surgery - Product Code GBO
• Product: Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261; ; 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: 1/22/2018 - 10/24/2021; Batch: 16682515 18351959 19879547 16954904 18518065 20221526 17023624 18662849 20491742 17174677 18689958 20593965 17547901 18773158 20703428 17634224 18821699 20798225 17797370 18898592 20824604 17881031 19103570 20872724 17990643 19134817 20995561 18006579 19185066 21055681 18141765 19235546 21101919 18280356 19368679 21179390
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Donna M. Gardner; 508-683-4398
• Manufacturer Reason for Recall: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
• FDA Determined Cause: 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: 1480
• 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.