Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-1101-2018)

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: M0064101010, GTIN: 08714729005278 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-1101-2018

Event ID: 79424

Reason for Recall:

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

Status: Terminated

Product Quantity: 1716

Code Information:

Expiration Date Range: 1/22/2018 - 10/4/2021; Batch: 16682347 18705536 20623819 16893775 18773341 20658861 16943409 18876327 20685659 17003572 18898595 20735791 17017122 18987890 20798226 17075064 19058167 20830240 17184857 19515680 20884480 17192710 19900108 20909296 17603504 20094213 20942365 17703884 20261038 21055683 17797369 20312726 21129580 17990644 20401204 21157953 18084498 20458382 21179391 18095911 20491743 21218849 18691891 20517726

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