WATCHDOGRecalls & reported problems across all models

We found 2 models of WATCHDOG by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2022 and Jun 4, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

WATCHDOG recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 ↗

2. 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 WATCHDOG problems

WATCHDOG models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WATCHDOG™ H74939343A020

  Wire, guide, catheter
  2 recalls2 reports
• WATCHDOG™ H74939343020

  Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
  3 reports

Recent WATCHDOG adverse event reports

The 5 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT VALVE ISSUES OCCURRED CAUSING AIR EMBOLISM AND PATIENT INSTABILITY. A WATCHDOG HEMOSTASIS VALVE WAS SELECTED FOR USE. DURING THE PROCEDURE, VALVE ISSUES WERE ENCOUNTERED, AIR ENTERED THE SYSTEM AND THE VESSEL, WHICH CREATED SOME INITIAL PATIENT INSTABILITY. IT WAS NOTED THAT FLUSHING AND WAITING RESOLVED THE ISSUE. THE REMAINDER OF THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY USING AN ALTERNATE DEVICE AND THE PATIENT WAS FINE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Air Embolism; Insufficient Information

  MAUDE report 22146753 ↗
• InjuryNov 27, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AIR EMBOLISM OCCURRED REQUIRING INTERVENTION. A WATCHDOG HEMOSTASIS VALVE WAS SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. DURING THE PROCEDURE, AN AIR EMBOLISM WAS INTRODUCED VIA THE GUIDE CATHETER. IT WAS NOTED THAT THE CAUSE IS RELATED TO THE WATCHDOG DEVICE. CONSEQUENTLY, THE PATIENT HAD ST ELEVATION AND MAY HAVE GOTTEN A LITTLE SICK BUT WAS ULTIMATELY FINE. CODE STRATEGIES WERE EXECUTED, AND THE PATIENT WAS SUCCESSFULLY REVIVED FROM COMPLICATIONS. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE. THE PATIENT FULLY RECOVERED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ORIGINAL METHOD AND/OR DEVICE. IT WAS FURTHER REPORTED THAT THE PATIENT SUSTAINED AN AIR EMBOLISM THAT RESULTED IN VENTRICULAR FIBRILLATION. THE PATIENT WAS RESUSCITATED SUCCESSFULLY, ADMITTED TO THE HOSPITAL FOR FOLLOW UP CARE AND DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes; Ventricular Fibrillation

  MAUDE report 20800656 ↗
• 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 ↗
• MalfunctionJul 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LOSS OCCURRED. A WATCHDOG HEMOSTASIS VALVE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WATCHDOG WAS LEAKING AN EXCESSIVE AMOUNT OF BLOOD. THE TUBING WAS REPLACED THREE TIMES AND THE LEAKING WAS NOT RESOLVED. A NEW WATCHDOG WAS SELECTED AND THERE WAS NO LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15019143 ↗

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