FDA recall Z-1592-2023

Boston Scientific Corporation · Class II · device

Product

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.

Distribution

Worldwide

Key facts

Status
Ongoing
Initiation date
2023-04-05
Report date
2023-05-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1592-2023