Recall Z-1592-2023— Boston Scientific Corporation

Name: FDA recall Z-1592-2023
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 Hemostasis Valve Kit, UPN H74939343A022 (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 Hemostasis Valve Kit, UPN H74939343A022 (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.