Z-1592-2023Class II

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

Name: Z-1592-2023 WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Creator: Boston Scientific Corporation
Published: 2023-04-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2023-04-05 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package) on 2023-04-05. FDA classified it as Class II and gives the reason as "The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1592-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-05
Posted: 2023-05-16
Recalling firm: Boston Scientific Corporation
Product: WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Boston Scientific issued an URGENT MEDICAL DEVICE PRODUCT REMOVAL notice on 04/05/2023 by overnight mail. The notice explained the issue and the hazard and requested the consignee segregate the devices pending return. Medical facilities who distributed the devices and distributors were directed to send the notice to their customers.
Quantity in commerce: 1300 units
Distribution: Worldwide
Product codes and lots: GTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1592-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1592-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-16
Z-1593-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-16

Product code DTL

K172453Class IIWATCHDOG Hemostasis Valve KitBoston Scientific Corporation / cleared 2017-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)