Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-1099-2018)

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 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.

Product Classification:

Class II

Date Initiated: December 12, 2017

Date Posted: March 28, 2018

Recall Number: Z-1099-2018

Event ID: 79424

Reason for Recall:

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

Status: Terminated

Product Quantity: 422

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

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