Boston Scientific Corporation: 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

Recall number

Z-1103-2018

Recalling firm

Boston Scientific Corporation

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

Status

Terminated

Initiated

2017-12-12

Posted

not on file

Terminated

2019-10-24

Reason

Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.

Root 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

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

GBO

Firm FEI

3005099803

Firm city

Marlborough

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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