Reported May 24, 2023 · Ongoing

WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565

Is this the product you have?

    • WATCHDOG Hemostasis Valve Kit
    • UPN H74939343A022 (outer package)
    • UPN H74939343A020 (inner package)
Lot codes and dates
    • GTIN 08714729996019 (outer package)
    • GTIN 08714729965794 (inner package)
  • Batch numbers
    • 30272850
    • 30542947
    • 30661041
    • 30845826
    • 30935565
Amount recalled
1300 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.