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U.S. Department of Health and Human Services

Class 2 Device Recall Malecot Nephrostomy Catheter System

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  Class 2 Device Recall Malecot Nephrostomy Catheter System 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-1099-2018
Recall Event ID 79424
510(K)Number K811378  
Product Classification Catheter, peritoneal - Product Code GBW
Product Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980

The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy Catheter with its extended tip is also designed for internal drainage from the ureteropelvic junction to the bladder.
Code Information Expiration Date Range: 2/28/2018 - 6/30/2020; Batch: 17885402 19389759 20484324 18312368 19423001 20602275 18795228 19652457 20346010 19009720 19682505 20484324 19104130 19910674 20602275 19247419 20346010
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 422
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.
510(K) Database 510(K)s with Product Code = GBW and Original Applicant = MEDI-TECH, INC.