TRUWAVE, VAMP PLUS PXVP2284AT3Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07460691950436), received between Jan 24, 2024 and Jun 30, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Contamination” (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, 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE VAMP, THE BACK END OF THE DEVICE BECAME DISCONNECTED FROM THE PLUNGER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367529 ↗
• MalfunctionMay 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, WHILE POWER FLUSHING, THE PIGTAIL OF A TRUWAVE BROKE. PER THE CUSTOMER, AN ACCURATE BLOOD PRESSURE WAS UNABLE TO BE OBTAINED AND THE ALINE WAS AT RISK FOR CLOTTING. THE DEVICE WAS EXCHANGED FOR A NEW ONE. THERE WERE NO PATIENT INJURIES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953223 ↗
• MalfunctionApr 23, 2025Disconnection; Disconnection

  IT WAS REPORTED BEFORE USE THAT THE ARTERIAL LINE BECAME DETACHED WITH THE PRESSURE MONITORING SET. A FAMILY MEMBER WAS SPLASHED WITH IV SOLUTION, NOT BLOOD. THERE WAS NO HARM OR INJURY TO THE FAMILY MEMBER. THE EDWARDS REPRESENTATIVE PROVIDED ON-SITE EDUCATION. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894142 ↗
• MalfunctionApr 23, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT BEFORE USE WITH A PRESSURE MONITORING SET THAT THERE WAS A TUBE THAT BECAME DETACHED. THE FACILITY IS UNABLE TO INDICATE THE LOCATION OF THE TUBING THAT BECAME DETACHED. THE USER HAD TIGHTENED ALL THE CONNECTIONS. THERE IS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894120 ↗
• MalfunctionMar 19, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE CUSTOMER NOTICED A PXVP2284AT3 WITH EXCESSIVE SILICONE IN THE SYRINGE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937660 ↗
• MalfunctionJan 24, 2024Contamination; Contamination

  IT WAS REPORTED THAT A TRUWAVE VAMP HAD SILICONE OVERSPRAY. ISSUE WAS NOTICED PRIOR TO USE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574677 ↗
• MalfunctionJan 24, 2024Contamination; Contamination

  IT WAS REPORTED THAT A TRUWAVE VAMP HAD SILICONE OVERSPRAY. ISSUE WAS NOTICED PRIOR TO USE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574638 ↗
• MalfunctionJan 24, 2024Contamination; Contamination

  IT WAS REPORTED THAT VISCOUS FLUID WAS FOUND IN THE RESERVOIR OF A TRUWAVE VAMP DURING DEVICE SET UP. HOSPITAL STAFF NOTICED THAT A RING IN THE SYRINGE WAS LEFT BEHIND FROM THE FLUID WHEN PUSHING THE PLUNGER UP AND BACK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574561 ↗
• MalfunctionJan 24, 2024Contamination; Contamination

  IT WAS REPORTED THAT VISCOUS FLUID WAS FOUND IN THE RESERVOIR OF A TRUWAVE VAMP DURING DEVICE SET UP. HOSPITAL STAFF NOTICED THAT A RING IN THE SYRINGE WAS LEFT BEHIND FROM THE FLUID WHEN PUSHING THE PLUNGER UP AND BACK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574525 ↗

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