TRUWAVE, VAMP PXVMP184Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07460691955103), received between Jul 15, 2024 and Mar 17, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, IN THIS PRESSURE MONITORING SET WITH VAMP, THE PRESSURE TUBING BROKE NEAR THE VAMP RESERVOIR. THERE WAS NO PATIENT INJURY. AS PER PRODUCT EVALUATION, THE PRESSURE TUBING WAS FOUND COMPLETELY DETACHED FROM THE VAMP RESERVOIR STOPCOCK BOND JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615197 ↗
• MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING BLOOD SAMPLING WITH THIS PRESSURE MONITORING SET, THE VAMP TUBING DETACHED. THE TUBING COULD NOT BE REASSEMBLED AS IT WAS COMPLETELY DETACHED. IT WAS NOTED THAT THIS ISSUE HAS OCCURRED PREVIOUSLY. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923290 ↗
• MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING BLOOD SAMPLING WITH THIS PRESSURE MONITORING SET, THE VAMP TUBING DETACHED. THE TUBING COULD NOT BE REASSEMBLED AS IT WAS COMPLETELY DETACHED. IT WAS NOTED THAT THIS ISSUE HAS OCCURRED PREVIOUSLY. THERE IS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923169 ↗
• MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING FLUSHING AND AFTER DRAWING A BLOOD SAMPLE, IN THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP, THE PRESSURE TUBING DETACHED FROM THE RESERVOIR. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393190 ↗
• MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING FLUSHING AND AFTER DRAWING A BLOOD SAMPLE, IN THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP, THE PRESSURE TUBING DETACHED FROM THE RESERVOIR. THERE WAS NO BLOOD LOSS. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393066 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, THIS DISPOSABLE PRESSURE TRANSDUCER PRESSURE TUBING DETACHED NEAR THE VAMP SYSTEM. THERE WAS 2 ML OF BLOOD LOSS. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS REPLACED WITH A NEW UNIT. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22381340 ↗
• MalfunctionMar 20, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE IV TUBING OF A VAMP PRESSURE TUBING BROKE AND DISCONNECTED AT THE VAMP. THIS OCCURRED UPON DRAWING BACK ON VAMP DURING BLOOD SAMPLING. THERE WERE NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660114 ↗
• MalfunctionMar 20, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A VAMP PRESSURE TUBING BROKE AT THE VAMP ON THE IV SIDE. EVENT OCCURRED DURING ROUTINE BLOOD DRAW OFF THE ARTERIAL LINE, TWO DAYS AFTER SET UP. THE POINT OF DISCONNECTION WAS NOT A LUER SLIP NOR LUER LOCK AND THE LINE WAS UNABLE TO BE RE-ATTACHED. THIS PRESSURE TUBING WAS EXCHANGED FOR A NEW SET UP. THERE WERE NO INJURIES TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660113 ↗
• MalfunctionJul 15, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT DURING USE OF THE PXVMP184 VAMP PRESSURE MONITORING SET, THE ARTERIAL LINE TUBING WAS MALFUNCTIONING. THE NEW SET-UP OF THE SALINE FLUSH BAG WAS INFUSED OVER APPROXIMATELY 1-2 HOURS, 500ML OF FLUID WAS INSTILLED. THERE WAS NO ADDITIONAL TREATMENT REQUIRED TO THE PATIENT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747044 ↗
• MalfunctionJul 15, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT DURING USE OF THE PXVMP184 VAMP PRESSURE MONITORING SET, THE ARTERIAL LINE TUBING WAS MALFUNCTIONING. THE NEW SET-UP OF THE SALINE FLUSH BAG WAS INFUSED OVER APPROXIMATELY 1-2 HOURS, 500ML OF FLUID WAS INSTILLED. THERE WAS NO ADDITIONAL TREATMENT REQUIRED TO THE PATIENT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747042 ↗

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-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-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-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-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-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-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-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