WATCHDOG™ H74939343A020Recalls & reported problems
Boston Scientific Corporation · Hemostasis Valve Kit · Class 2
All models of WATCHDOG (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729965794), received between Feb 23, 2024 and Apr 3, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Apr 5, 2023Open, Classified
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Z-1593-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 5, 2023Open, Classified
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Z-1592-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device1
- Device-Device Incompatibility1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DEVICE CAUSED AN AIR INTRODUCTION TO THE SYSTEM. A WATCHDOG HEMOSTASIS VALVE KIT WAS SELECTED FOR USE. DURING THE PREPARATION, IT WAS NOTED THAT THE WATCHDOG VALVE FAILED WHEN ATTACHED TO BOSTON SCIENTIFIC CRYO BALLOON. THE IRRIGATION PORT OF THE VALVE CAME LOOSE WHICH CAUSING AIR INTRODUCTION TO THE SYSTEM. THIS DID NOT IMPACT THE PATIENT AS IT WAS NOT IN THE BODY AT THE TIME. NO PATIENT COMPLICATIONS WERE REPORTED POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19034547 ↗InjuryFeb 23, 2024Loose or Intermittent Connection; Air/Gas in Device
BOSTON SCIENTIFIC WATCHDOG VALVE FAILED WHEN ATTACHED TO BOSTON SCIENTIFIC CRYO BALLOON. THE IRRIGATION PORT OF THE VALVE CAME LOOSE DURING PREP, CAUSING AIR INTRODUCTION TO THE SYSTEM. THIS DID NOT IMPACT THE PATIENT AS IT WAS NOT IN THE BODY AT THE TIME. THIS HAS HAPPENED IN TWO PREVIOUS CASES. THE PLASTIC THREADS WILL STRIP EASILY AND SHOULD NOT BE USED WITH THIS SYSTEM SET UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18782497 ↗
Other Wire, guide, catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page