TRUWAVE, VAMP PLUS PXVP2284Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07460691950177), received between May 18, 2023 and Nov 26, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

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

11 other recalls cover devices cleared under the same FDA submission (K142749, K181684, K896819); 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-0414-2024 · Root cause: Device Design · 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.

• MalfunctionNov 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, A PRESSURE MONITORING DEVICE HAD INACCURATE PRESSURE READINGS COMPARED TO AN ARM CUFF. A-LINE READ 102/54 AND THE ARM CUFF READ 197/44. IT WAS STATED THAT THE A-LINE HAD GOOD SQUARE WAVEFORM AND ALL APPROPRIATE TROUBLESHOOTING WERE COMPLETED. NO ALLEGATIONS OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659314 ↗
• MalfunctionNov 11, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED DURING USE WITH THE PRESSURE MONITORING SET THAT THE ARTERIAL PRESSURE (SYSTOLIC, DIASTOLIC, AND MEAN) DID NOT CORRELATE WITH NIBP AND MANUAL PRESSURE. ADDITIONAL INFORMATION PROVIDED: NO ERROR MESSAGE OR ABNORMAL WAVEFORM WAS REPORTED. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525843 ↗
• MalfunctionJul 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE IN THE INTENSIVE CARE UNIT, THE SYSTOLIC BLOOD PRESSURE READING OF A PRESSURE MONITORING KIT WAS 40 TO 100 POINTS HIGHER THAN BOTH THE MANUAL AND AUTOMATIC CUFF PRESSURES. THOUGH THE MEAN ARTERIAL PRESSURE READINGS DID NOT CORRELATE, THE DIASTOLIC BLOOD PRESSURES WERE SIMILAR. ISSUE WAS RESOLVED BY REVIEWING THE CASE WITH A DOCTOR. NO ALLEGATIONS OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580981 ↗
• InjuryOct 9, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A CASE WITH AIR EMBOLISM WHILE BEING MONITORED WITH A VAMP CLOSED BLOOD SAMPLING SYSTEM. PER FOLLOW UP WITH CUSTOMER, DEVICE WAS A PXVP2284 AND LOT MAY HAVE BEEN 65769851. ISSUE OCCURRED DURING PROCEDURE AFTER FLUSHING A CONNECTED VAMP (TRUWAVE (3CC)/VAMP PLUS 84IN (210CM) TO AN EDWARDS PRESSURE MONITORING ACCESSORY TUBING (K16912A) WHICH WAS SECURED TO THE ARROW RADIAL ARTERY CATHETERIZATION SET (14F24D0309) CATHETER. FLUSHING OCCURRED WHEN THE SYSTEM WAS CONNECTED POST INSERTION. AFTER FLUSHING THE ARROW ARTERIAL LINE UTILIZING THE TOGGLE MECHANISM, THE PATIENT BECAME UNRESPONSIVE WITHOUT GAG REFLEX AND REQUIRED INTUBATION. THE TEAM WAS ABLE TO DIAGNOSE THE AIR EMBOLISM PER MRI. NO TROUBLESHOOTING STEPS WERE ATTEMPTED. PATIENT REMAINS IN ICU SINCE (B)(6) 2024 WITH ONGOING ENCEPHALOPATHY, R HEMIPARESIS AND RESPIRATORY FAILURE ON MECHANICAL VENTILATION. PATIENT IS A 66 Y/O FEMALE, , 73.5 KG, PMH HYPERTENSION, HYPERLIPIDEMIA, DM II, HYPOTHYROIDISM, PRIMARY HYPERPARATHYROIDISM DUE TO PARATHYROID ADENOMA S/P PARATHYROIDECTOMY, AND BREAST CANCER DX 1994 WITH RECURRENCE (2020) S/P CHEMOTHERAPY, BILATERAL MASTECTOMY, AND ANASTROZOLE SINCE (B)(6)

  Patient problems: Air Embolism

  MAUDE report 20408404 ↗
• MalfunctionOct 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A TRANSDUCER HAS INCORRECT BLOOD PRESSURE READING WITH WIDE PULSE PRESSURES. NO ALLEGATIONS OF PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17991081 ↗
• MalfunctionMay 18, 2023Fluid/Blood Leak; Defective Component

  AN ARTERIAL LINE AND PRESSURE BAG WAS CONNECTED TO A DRAW SYSTEM THAT LINKED TO PATIENT'S PICC LINE. THE DRIP CHAMBER BEGAN LEAKING SPECIFICALLY BELOW THE WHITE SPIKE MATERIAL AND THE CLEAR PLASTIC DRIP CHAMBER. AFTER THE PRESSURE BAG/DRAW SYSTEM WAS SETUP; A SMALL PUDDLE WAS NOTICED ON THE FLOOR FROM THE DRIPPING. THE PICC LINE CONNECTED TO THE TUBING AND DRAW SYSTEM WAS LOCKED AND NEVER CAME INTO CONTACT WITH UNSTERILE MATERIALS. THIS GOOD CATCH RESULTED IN NO PATIENT HARM. THE LEAKING PRESSURE SYSTEM WAS CHANGED OUT AND THE NEW TUBING AND DRIP CHAMBER HAD NO LEAK. THE SET IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR INSPECTION. MANUFACTURER TO CONTACT WRITER WITH RETURN INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952659 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142749, K181684, K896819. One submission often covers many models, so check the product and lot details in each record.

• Z-0413-2024 · Oct 4, 2023 · Open, Classified
  TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc),
• 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-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-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-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-1966-2021 · May 26, 2021 · Terminated
  Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
• 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
• Z-1146-2013 · Jan 30, 2013 · Terminated
  Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762