TRUWAVE PXMK2041Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07460691951464), received between Mar 28, 2024 and Feb 6, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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

10 other recalls cover devices cleared under the same FDA submission (K142749); they may or may not involve this specific model.

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.

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-0413-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Inaccurate Flow Rate; Inaccurate Delivery; Inaccurate Flow Rate; Inaccurate Delivery

  AS REPORTED; AFTER OBSERVING A DAMPED WAVEFORM DURING USE IN PATIENT OF THIS DISPOSABLE PRESSURE TRANSDUCER (REPORT REF 2015691-2025-00807), IT WAS DETECTED A PROBLEM IN THE SALINE FLOW RATE. IT LED TO THE SALINE BAG OF 500 ML GETTING EMPTY AND THE SOLUTION ENTERING THE PATIENT IN LESS THAN 24 HOURS. ANOTHER TRANSDUCER (REPORT REF 2015691-2025-00808) AND SALINE BAG WERE CHANGED BUT THE SAME ISSUE OCCURRED, LEADING TO OTHER 500 ML OF SALINE ENTERING THE PATIENT. A TOTAL OF 1000 ML OF SALINE ENTERED THE PATIENT IN 48 HOURS. THERE WAS A LEVEL INCREASE TO 150 MEQ/L NA+ IN THE ARTERIAL BLOOD GAS. THE DEVICE WAS REPLACED WITH A NEW UNIT AND THE ISSUE WAS SOLVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321847 ↗
• MalfunctionFeb 6, 2025Inaccurate Flow Rate; Inaccurate Delivery; Inaccurate Flow Rate; Inaccurate Delivery

  AS REPORTED; AFTER OBSERVING A DAMPED WAVEFORM DURING USE IN PATIENT OF THIS DISPOSABLE PRESSURE TRANSDUCER (REPORT REF 2015691-2025-00807), IT WAS DETECTED A PROBLEM IN THE SALINE FLOW RATE. IT LED TO THE SALINE BAG OF 500 ML GETTING EMPTY AND THE SOLUTION ENTERING THE PATIENT IN LESS THAN 24 HOURS. ANOTHER TRANSDUCER (REPORT REF 2015691-2025-00808) AND SALINE BAG WERE CHANGED BUT THE SAME ISSUE OCCURRED, LEADING TO OTHER 500 ML OF SALINE ENTERING THE PATIENT. A TOTAL OF 1000 ML OF SALINE ENTERED THE PATIENT IN 48 HOURS. THERE WAS A LEVEL INCREASE TO 150 MEQ/L NA+ IN THE ARTERIAL BLOOD GAS. THE DEVICE WAS REPLACED WITH A NEW UNIT AND THE ISSUE WAS SOLVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321840 ↗
• MalfunctionMar 28, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT IN A LIFE-THREATENING EMERGENCY, THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) (2024-06126-01) UNSCREWED WHEN CONNECTED TO THE ARTERIAL ACCESS. IT WAS NECESSARY TO REDO THE ENTIRE ASSEMBLY OF THE PRESSURE LINE BY MANUALLY CONTINUING THE PURGE ON THE ARTERIAL LINE IN ORDER TO PREVENT IT FROM CLOGGING. TO SOLVE THE ISSUE, A NEW DEVICE WAS OPENED (2024-06126-02), HOWEVER, IT PRESENTED THE SAME ISSUE AS TWO OF THE SCREW THREADS WERE INSUFFICIENTLY SCREWED. ALL SCREW THREADS WERE CHECKED BEFORE NEW CONNECTION. PATIENT DEMOGRAPHICS ASKED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990248 ↗
• MalfunctionMar 28, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT IN A LIFE-THREATENING EMERGENCY, THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) (MEDWATCH # 45420) UNSCREWED WHEN CONNECTED TO THE ARTERIAL ACCESS. IT WAS NECESSARY TO REDO THE ENTIRE ASSEMBLY OF THE PRESSURE LINE BY MANUALLY CONTINUING THE PURGE ON THE ARTERIAL LINE IN ORDER TO PREVENT IT FROM CLOGGING. TO SOLVE THE ISSUE, A NEW DEVICE WAS OPENED (MEDWATCH # 45423), HOWEVER, IT PRESENTED THE SAME ISSUE AS TWO OF THE SCREW THREADS WERE INSUFFICIENTLY SCREWED. ALL SCREW THREADS WERE CHECKED BEFORE NEW CONNECTION. PATIENT DEMOGRAPHICS ASKED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142749. One submission often covers many models, so check the product and lot details in each record.

• Z-0414-2024 · Oct 4, 2023 · Open, Classified
  TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm)
• Z-1962-2021 · May 26, 2021 · Terminated
  Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
• Z-1964-2021 · May 26, 2021 · Terminated
  Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
• Z-1961-2021 · May 26, 2021 · Terminated
  Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***N
• Z-1966-2021 · May 26, 2021 · Terminated
  Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
• Z-1960-2021 · May 26, 2021 · Terminated
  Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
• Z-1963-2021 · May 26, 2021 · Terminated
  Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
• Z-1959-2021 · May 26, 2021 · Terminated
  Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
• Z-1965-2021 · May 26, 2021 · Terminated
  Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
• Z-2776-2015 · Jul 31, 2015 · Terminated
  Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For