TRUWAVE, VAMP PXAVMPRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00690103011494), received between Oct 25, 2024 and Mar 13, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 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, K173586, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 4, 2023Class IIOpen, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH A PRESSURE MONITORING KIT. THE TUBING ON THE DEVICE BROKE AND BECAME DISCONNECTED ON THE PATIENT SIDE OF THE FLOW RESTRICTOR. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595172 ↗
• MalfunctionMar 13, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH A PRESSURE MONITORING KIT. THE TUBING ON THE DEVICE BROKE AND BECAME DISCONNECTED ON THE PATIENT SIDE OF THE FLOW RESTRICTOR. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595164 ↗
• MalfunctionMar 13, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH A PRESSURE MONITORING KIT. THE TUBING ON THE DEVICE BROKE AND BECAME DISCONNECTED ON THE PATIENT SIDE OF THE FLOW RESTRICTOR. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595090 ↗
• MalfunctionMar 13, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH A PRESSURE MONITORING KIT. THE TUBING ON THE DEVICE BROKE AND BECAME DISCONNECTED ON THE PATIENT SIDE OF THE FLOW RESTRICTOR. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595070 ↗
• MalfunctionMar 13, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH A PRESSURE MONITORING KIT. THE TUBING ON THE DEVICE BROKE AND BECAME DISCONNECTED ON THE PATIENT SIDE OF THE FLOW RESTRICTOR. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595050 ↗
• MalfunctionNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING USE THAT THE PXAVMP VAMP AND TUBING SEPARATED CAUSING BACKFLOW OF BLOOD OUT OF THE PATIENT WHEN THE PRIMARY NURSE WAS LEVELING THE TRANSDUCER OF THE ARTERIAL LINE. WITH TIMELY INTERVENTION THE LINE WAS PRESERVED AND PATIENT BLOOD LOSS WAS MINIMAL. THERE WAS NO SUBSTANTIAL PRESSURE APPLIED TO THE CONNECTION IN THE PROCESS OF LEVELING THE TRANSDUCER AND MINIMAL MANIPULATION OF THE LINE DURING MOVEMENT. ANOTHER IDENTICAL DEVICE WAS OBTAINED AND USED ON THE PATIENT AND NO HARM OCCURRED FROM THIS EVENT. SUBJECT WAS A 41 YEAR OLD MALE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20614904 ↗
• MalfunctionOct 25, 2024

  PRIMARY NURSE WAS LEVELING THE TRANSDUCER OF THE ARTERIAL LINE, THE VAMP AND TUBING SEPARATED CAUSING BACK FLOW OF BLOOD OUT OF THE PATIENT. WITH TIMELY INTERVENTION, THE LINE WAS PRESERVED, AND PATIENT BLOOD LOSS WAS MINIMAL. I WAS AT THE BEDSIDE ASSISTING WITH REPOSITIONING AT THE TIME, THERE WAS NO SUBSTANTIAL PRESSURE APPLIED TO THE CONNECTION IN THE PROCESS OF LEVELING THE TRANSDUCER AND MINIMAL MANIPULATION OF THE LINE DURING MOVEMENT. ANOTHER IDENTICAL DEVICE WAS OBTAINED AND USED ON PATIENT AND NO HARM OCCURRED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142749, K173586, 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-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-1966-2021 · May 26, 2021 · Terminated
  Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
• 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-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-1962-2021 · May 26, 2021 · Terminated
  Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
• 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