FDA-Device2023-05-24Class II
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
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-1592-2023More Boston Scientific Corporation recalls
- FDA-Device2026-07-29Boston Scientific FARADRIVE steerable sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for catheter incompatibility
- FDA-Device2026-07-29Boston Scientific FARASTAR Ablation Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
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