FDA-Device2023-05-24Class II
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (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
10833 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1593-2023Don't want to check this manually?
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