Recall Z-3148-2024— Boston Scientific Corporation

Name: FDA recall Z-3148-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-18

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2024-07-18. It names one FDA 510(k) clearance: K211934. Product: Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail. Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-07-18
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K211934 — APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenbergBoston Scientific Corporation·cleared 2022-11-10

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

Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail

Reason for recall

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

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