Recall Z-1099-2018— Boston Scientific Corporation

Name: FDA recall Z-1099-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-12

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2017-12-12, terminated 2019-10-24. It names one FDA 510(k) clearance: K811378. 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.. Reason: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-12-12
Terminated: 2019-10-24
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K811378 — PERCUTANEOUS DRAINING CATHETERMedi-Tech, Inc.·cleared 1981-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.