Recall Z-1593-2023— Boston Scientific Corporation

Name: FDA recall Z-1593-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-05

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2023-04-05. It names one FDA 510(k) clearance: K172453. Product: WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package). Reason: The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-04-05
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K172453 — WATCHDOG Hemostasis Valve KitBoston Scientific Corporation·cleared 2017-11-09

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

WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)

Reason for recall

The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

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