FDA-Device2023-05-24Class II
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Boston Scientific Corporation
Hazard
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Sold states
Worldwide
Affected count
1300 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1592-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief