FDA recall Z-1593-2023

Boston Scientific Corporation · Class II · device

Product

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.

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-1593-2023