WATCHDOG™ H74939343020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729965787), received between Jul 14, 2022 and Jun 4, 2025 — classified as 2 injuries, 1 malfunction.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, 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 ↗
• 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 ↗