CLASS II ONGOING Device recall · Reported 24 May 2023 · FDA Enforcement Report

Watchdog Hemostasis Valve Kit, UPN H74939343A022 recalled

Boston Scientific is recalling Watchdog Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020. The recall was initiated on 5 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565

Quantity recalled1300 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1592-2023
FDA event ID: 92072
Recalling firm: Boston Scientific, Maple Grove, MN
Classification: Class II
Status: Ongoing
Recall initiated: 5 Apr 2023
FDA classified: 16 May 2023
Reported: 24 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

5 Apr 2023	Recall initiated by company
16 May 2023	Classified by FDA	+41 days
24 May 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Worldwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

GTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 92072

Reported	Class	Recall	Company	Reason	Where
24 May 2023	CLASS II	Watchdog Accessory Kit, Upn H74939343A021 (outer package) recalled	Boston Scientific	Packaging Defects	MN

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