Boston Scientific Corporation recalls Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting M

Recalled March 28, 2018 · FDA recall Z-1099-2018 · Boston Scientific

Hazard

Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. · FDA Class II

Units

422

Sold at

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.

Description

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

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.

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →