Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-1100-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 12, 2017

Date Posted: March 28, 2018

Recall Number: Z-1100-2018

Event ID: 79424

Reason for Recall:

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

Status: Terminated

Product Quantity: 1480

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated