Recall Z-1099-2018 ยท GBW Catheter, Peritoneal
Boston Scientific Corporation
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.
| Date | Dec 12, 2017 |
| Status | Terminated |
| 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 R |
| Quantity | 422 |
| 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: Arge |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811378 | PERCUTANEOUS DRAINING CATHETER Medi-Tech, Inc., Jun 2, 1981 |