TRUWAVE, VAMP JR. VMP306PXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07460691950375), received between May 24, 2018 and Jan 16, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

12 other recalls cover devices cleared under the same FDA submission (K142749, 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.

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.

• MalfunctionJan 16, 2026Air/Gas in Device

  IT WAS REPORTED THAT DURING USE OF THE PRESSURE MONITORING SET THE TEAM NOTICED THAT THE LINE STOPPED READING. UPON CHECKING THE LINE THE TEAM DISCOVERED BUBBLES IN THE LINE AND ATTEMPTED TO CLEAR THEM BUT KEPT PULLING AIR AND COULD NOT IDENTIFY WHERE THE AIR WAS COMING FROM. THEY FOUND THAT THE AIR WAS IN THE SYRINGE CONNECTED TO THE LINE TO TAKE A BLOOD SAMPLE. THEY DID LOOK AT THE FLUIDS HANDING AND THERE WERE WAS NOT ANY AIR IN THE BAG OR THE LINE. THIS WAS USED IN CONJUNCTION WITH THE ARGYLE UMBILICAL VESSEL CATHETER 3.5 FRENCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097418 ↗
• MalfunctionJun 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A VMP306PX TRUWAVE 30CC VAMP JR FROM LOT 64615627, HAD SNAPPED IN THE MIDDLE OF THE DEVICE. IT HAD NOT BEEN USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075988 ↗
• InjuryJul 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THIS VAMP JR., THERE WAS BLOOD BACKING UP IN THE TUBING AND THERE WAS LEAKAGE FROM THE CONNECTION POINT ON THE TRANSDUCER. THERE WAS NO PATIENT HARM, HOWEVER, THERE WAS 1ML OF BLOOD LOSS. THE PATIENT WAS AN INFANT AT (B)(6) GEST AGE, (B)(6) GRAMS, (B)(6) DAY OLD. THERE WAS NO PROCEDURE BEING CONDUCTED, HAD JUST HUNG IV FLUIDS. NURSE WAS AT BEDSIDE AT TIME AND REPORTED FLUID LOSS WAS MINIMAL. BABY DID RECEIVE A TRANSFUSION AFTER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100867 ↗
• MalfunctionMay 24, 2018Device Inoperable

  VAMP JR TRANSDUCER WOULD NOT READ ARTERIAL BLOOD PRESSURE OR PULSE RATE. NEW TRANSDUCER WAS OBTAINED AND WORKED APPROPRIATELY. DEVICE IS IN MY POSSESSION HOWEVER PACKING WAS NOT RETAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7540245 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142749, 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-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-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-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-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-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