TruWave, VAMP T001744MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07460691959507), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (6 reports).

1 FDA recall record name this device's identifier, 1 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.

Recalls naming this device

1. Oct 4, 2023Open, Classified

   Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

   Z-0414-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Obstruction of Flow; Obstruction of Flow

  AS REPORTED, DURING USE OF THIS PRESSURE MONITORING SET IN THE PREVIOUS 1-2 WEEKS, DAMPED WAVEFORM WAS OBSERVED, SO DEVICE WAS CHECKED AND CONFIRMED THERE WERE NO KINKS AND SALINE BAG WAS FULLY PRESSURIZED. AFTER REMOVING THE LINE, BLOOD CLOT APPEARED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Embolism/Embolus

  MAUDE report 21891018 ↗
• MalfunctionApr 23, 2025Obstruction of Flow; Obstruction of Flow

  AS REPORTED, DURING USE OF THIS PRESSURE MONITORING SET IN THE PREVIOUS 1-2 WEEKS, DAMPED WAVEFORM WAS OBSERVED, SO DEVICE WAS CHECKED AND CONFIRMED THERE WERE NO KINKS AND SALINE BAG WAS FULLY PRESSURIZED. AFTER REMOVING THE LINE, BLOOD CLOT APPEARED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Embolism/Embolus

  MAUDE report 21890926 ↗
• InjuryApr 23, 2025Obstruction of Flow; Obstruction of Flow

  AS REPORTED, DURING USE IN PATIENT OF THIS PRESSURE MONITORING SET, THERE WERE BLOOD CLOTS IN BOTH ARMS AND IT WAS NOT POSSIBLE TO PLACE ANOTHER ARTERIAL LINE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Embolism/Embolus

  MAUDE report 21890866 ↗
• MalfunctionApr 23, 2025Obstruction of Flow; Obstruction of Flow

  AS REPORTED, DURING USE OF THIS PRESSURE MONITORING SET IN THE PREVIOUS 1-2 WEEKS, DAMPED WAVEFORM WAS OBSERVED, SO DEVICE WAS CHECKED AND CONFIRMED THERE WERE NO KINKS AND SALINE BAG WAS FULLY PRESSURIZED. AFTER REMOVING THE LINE, BLOOD CLOT APPEARED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Embolism/Embolus

  MAUDE report 21890471 ↗
• MalfunctionApr 23, 2025Obstruction of Flow; Obstruction of Flow

  AS REPORTED, DURING USE OF THIS PRESSURE MONITORING SET IN THE PREVIOUS 1-2 WEEKS, DAMPED WAVEFORM WAS OBSERVED, SO DEVICE WAS CHECKED AND CONFIRMED THERE WERE NO KINKS AND SALINE BAG WAS FULLY PRESSURIZED. AFTER REMOVING THE LINE, BLOOD CLOT APPEARED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Embolism/Embolus

  MAUDE report 21890397 ↗
• MalfunctionApr 23, 2025Obstruction of Flow; Obstruction of Flow

  AS REPORTED, DURING USE OF THIS PRESSURE MONITORING SET IN THE PREVIOUS 1-2 WEEKS, DAMPED WAVEFORM WAS OBSERVED, SO DEVICE WAS CHECKED AND CONFIRMED THERE WERE NO KINKS AND SALINE BAG WAS FULLY PRESSURIZED. AFTER REMOVING THE LINE, BLOOD CLOT APPEARED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Embolism/Embolus

  MAUDE report 21890271 ↗