PlainRecalls
FDA Devices Moderate Class II Ongoing

WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

Reported: May 24, 2023 Initiated: April 5, 2023 #Z-1592-2023

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.

Details

Units Affected
1300 units
Distribution
Worldwide
Location
Maple Grove, MN

Frequently Asked Questions

What product was recalled?
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package). Recalled by Boston Scientific Corporation. Units affected: 1300 units.
Why was this product recalled?
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 24, 2023. Severity: Moderate. Recall number: Z-1592-2023.