TRUWAVE PX284Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07460691950214), received between Aug 8, 2024 and Mar 9, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Low Readings” (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, K171996, K183413); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Low Readings

  AS REPORTED, DURING USE IN AN INTENSIVE CARE PATIENT WITH DISSEMINATED INTRAVASCULAR COAGULATION (DIC), THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) CONNECTED TO THE RADIAL CATHETER, DISPLAYED AN ABNORMALLY LOW BLOOD PRESSURE VALUE. CONSEQUENTLY, THE PATIENT WAS TREATED WITH A HIGH DOSE OF VASOPRESSORS AS FLUID RESUSCITATION. SINCE THE VALUES DID NOT CHANGE AFTER ADMINISTERING MEDICATION, ANOTHER PRESSURE SENSOR WAS CONNECTED TO THE FEMORAL VEIN, WHICH SHOWED PRESSURE VALUES 10MMHG HIGHER, CONSIDERED CORRECT AS PER PATIENT CONDITION. ALSO A CUFF WAS CONNECTED AND SHOWED PRESSURE VALUES WHICH WERE IN BETWEEN THE RADIAL AND THE FEMORAL VALUES AND WERE ALSO CONSIDERED TO BE CORRECT. THERE WAS NO ERROR MESSAGE DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 24544725 ↗
• InjuryMar 9, 2026Low Readings

  AS REPORTED, DURING USE IN AN INTENSIVE CARE PATIENT WITH DISSEMINATED INTRAVASCULAR COAGULATION (DIC), THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) CONNECTED TO THE RADIAL CATHETER, DISPLAYED AN ABNORMALLY LOW BLOOD PRESSURE VALUE. THERE WAS NO ERROR MESSAGE DISPLAYED. CONSEQUENTLY, THE PATIENT WAS TREATED WITH A HIGH DOSE OF VASOPRESSORS AS FLUID RESUSCITATION. SINCE THE VALUES DID NOT CHANGE 3 HOURS AFTER ADMINISTERING THE MEDICATION, ANOTHER PRESSURE SENSOR WAS CONNECTED TO THE FEMORAL VEIN, WHICH SHOWED PRESSURE VALUES CONSIDERED TO BE CORRECT OF 197MMHG/68MMHG. THE DPT SHOWED PRESSURE VALUES OF 131MMHG/59MM HG. ALSO, A CUFF WAS CONNECTED AND SHOWED PRESSURE VALUES WHICH WERE IN BETWEEN THE RADIAL AND THE FEMORAL VALUES AND WERE ALSO CONSIDERED TO BE CORRECT. DECREASING THE AMINES LED TO PATIENT IMPROVEMENT, AND THE VALUES FROM THE FEMORAL SENSOR SEEMED COHERENT WITH PATIENT CONDITION. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 24544585 ↗
• MalfunctionAug 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER TROUBLE SHOOTING THE MONITOR AND ASSOCIATED PARTS WHILE ATTEMPTING TO OBTAIN INTRA-VENOUS PRESSURES THE CATHETER CONTINUED MEASURING NEGATIVE VALUES BETWEEN: -2 TO -7 MM/HG . ANOTHER ARROW PRESSURE TUBING SETUP WAS USED TO VERIFY INACCURATE VALUES. ARROW SHOWED 5-7 MM/HG. MEASUREMENTS WERE -VENOUS BY BOTH ARROW PRESSURE TUBINGS. THE PRESSURE TRANSDUCER WAS REPLACED WITH A NEW ONE AFTER ALL OTHER TROUBLING SHOOTING WAS PERFORMED AND THE CUSTOMER WAS ABLE TO MEASURE IDEAL PRESSURES AROUND 5-7 MM/HG. WHICH WAS WITHIN EXPECTED RANGE FOR THE PATIENT PER MD PROVIDER. NO HARM CAME TO THE PATIENT, THE TRANSDUCER NOT MEASURING AN ACCURATE VALUE LIMITED THE PROVIDERS ABILITY TO MAKE SPECIFIC DIAGNOSIS. THE INTENDED PROCEDURE WAS A TRANS JUGULAR LIVER BIOPSY WITH INTRA-VENOUS PRESSURE MEASUREMENTS. THE PATIENT WAS NOT TREATED BASED ON THE INACCURATE VALUES; THE PROBLEM WAS RESOLVED PRIOR TO TREATMENT. DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939478 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142749, K171996, K183413. 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-1966-2021 · May 26, 2021 · Terminated
  Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
• 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-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-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-1962-2021 · May 26, 2021 · Terminated
  Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
• 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-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-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-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