TRUWAVE PX200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07460691950528), received between Feb 18, 2026 and Mar 3, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Inaccurate Delivery” (2 reports).

11 other recalls cover devices cleared under the same FDA submission (K142749, K171996); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Inaccurate Delivery

  AS REPORTED, DURING USE IN A NEONATAL PATIENT, THIS PRESSURE MONITORING KIT ADMINISTRATED TOO MUCH FLUID BECAUSE OF HIGHER FLOW RATE: FROM 0.2 TO 0.3 CC/HOUR. THE VOLUME OF SALINE ADMINISTRATED OVER 48 HOURS WAS ABOUT 120ML. ALL THE CONNECTIONS WERE CORRECTLY MADE. THEN, IT WAS DECIDED TO REMOVE THE UMBILICAL CATHETER. THE PATIENT HAD AN ELECTROLYTE IMBALANCE, GAINED TOO MUCH WEIGHT, AND SUFFERED A RESPIRATORY DEGRADATION. UNKNOWN MEDICATION WAS PROVIDED FOR IONIC REBALANCING. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: Hypervolemia; Unspecified Respiratory Problem; Weight Changes

  MAUDE report 24494587 ↗
• InjuryFeb 18, 2026Inaccurate Flow Rate; Inaccurate Delivery

  AS REPORTED, SEVERAL TIMES DURING 7 DAYS OF USE IN A PREMATURE BABY, THIS DISPOSABLE PRESSURE TRANSDUCER GOT DEPRESSURIZED CAUSING BACK FLOW AND A FLAT BLOOD PRESSURE CURVE. THE SYSTEM WAS FLUSHED AND PRESSURIZED EVERY TIME THE PROBLEM OCCURRED A PART FROM THE DAILY SYSTEM CHECKS. THE SYSTEM PRESSURE HAD TO BE ADJUSTED SEVERAL TIMES A DAY, WHICH IS UNUSUAL. ONE OF THE TIMES, THE SALINE BAG WAS NOTICED EMPTY. THIS MEANS THAT THE CHILD SHOULD HAVE RECEIVED 336 ML OVER 7 DAYS AND THAT THE ENTIRE 1-LITER BAG HAS BEEN CONSUMED. THE ENTIRE SYSTEM WAS REPLACED. THE CONSEQUENCES FOR THE PATIENT WERE ELECTROLYTE IMBALANCES, FAILURE TO INSERT A CENTRAL VENOUS CATHETER DUE TO EXCESSIVE LYMPHATIC FLUID, RESPIRATORY DIFFICULTIES WITH DELAYED EXTUBATING AND GAINED UP TO 310G BY DAY 4. THE PATIENT WAS TREATED WITH ANTIDIURETICS (LASILIX) AND HE IS OKAY.

  Patient problems: Hypervolemia; Unspecified Respiratory Problem; Weight Changes

  MAUDE report 24375460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142749, K171996. 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-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-1962-2021 · May 26, 2021 · Terminated
  Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
• 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-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-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