TRUWAVE, VAMP PXVMP172Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07460691955097), received between Sep 10, 2024 and Mar 13, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

12 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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionMar 13, 2026Detachment of Device or Device Component

  AS REPORTED DURING BLOOD SAMPLING DURING USE ON A PATIENT THE CONNECTION BETWEEN THE PATIENT SIDE THREE WAY STOPCOCK AND THE PLANECTA GOT LOOSENED AND DETACHED, THEN A SMALL AMOUNT OF BLOOD LEAKAGE OCCURRED. WHEN THE DEVICE WAS REPLACED, THE PROBLEM WAS SOLVED. THE PATIENT WAS AN ADULT. NO TRANSFUSION NOR EXTENSION OF HOSPITALIZATION WAS REQUIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24590294 ↗
• MalfunctionFeb 13, 2026Detachment of Device or Device Component

  AS REPORTED DURING USE THE PRESSURE MONITORING SET HAD BLOOD THAT BACKED UP INTO THE VAMP AND THE RN ATTEMPTED TO APPLY PRESSURE TO THE VAMP PLUNGER TO RETURN THE BLOOD. UPON DOING SO, THE TUBING PROXIMAL TO THE VAMP ON THE PATIENTS SIDE DISCONNECTED AT THE CONNECTION POINT. NO AIR WAS INTRODUCED AND THERE WAS MINIMAL BLOOD LOSS AS THE NURSE WAS PRESENT AT THE TIME OF DISCONNECTION. THE VAMP TUBING WAS CHANGED IMMEDIATELY. THERE WAS NO PATIENT INJURY. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24334256 ↗
• MalfunctionSep 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING SET UP OF THIS PRESSURE MONITORING SET, THE BONDING OF THE CONNECTOR AND TUBING WAS DETACHED. THERE WAS NO FURTHER INFORMATION AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186159 ↗

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