TRUWAVE PX600IRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07460691957077), received between Aug 21, 2024 and Apr 7, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Detachment of Device or Device Component

  AS REPORTED DURING USE THE PRESSURE MONITORING SET TRANSDUCER DISCONNECTED SPONTANEOUSLY AND CSF (CEREBROSPINAL FLUID) WAS LEAKING OUT OF IT. THE NURSE CHANGED OUT THE TRANSDUCER PER PROTOCOL. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS CONTAMINATED AND PICKED UP BY ANOTHER COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801323 ↗
• MalfunctionApr 7, 2026Detachment of Device or Device Component

  AS REPORTED DURING USE THE PRESSURE MONITORING SET TRANSDUCER FELL OFF ONTO THE FLOOR WHEN A PATIENT WAS UNDERGOING AN EXTERNAL VENTRICULAR DRAIN. THE EVD WAS ALREADY CLAMPED, SO THE PATIENT REMAINED SAFE. A NEW TRANSDUCER WAS APPLIED STERILE PER PROTOCOL. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS CONTAMINATED AND PICKED UP BY ANOTHER COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801145 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PX600I HAD LEAKAGE. ISSUE WAS NOTICED AFTER CONNECTING THE DEVICE TO AN EXTERNAL VENTRICULAR DRAINAGE AND FLUSHING. LEAKAGE WAS LIKELY SALINE, BUT COULD HAVE BEEN A SMALL AMOUNT OF CEREBRAL SPINAL FLUID. UPON INVESTIGATION, THE RN DISCOVERED THAT THE DISTAL END OF THE TRANSDUCER SPUN FREELY. AT THIS POINT, SHE ATTEMPTED TO TIGHTEN THE CONNECTION BUT COULD NOT. ANOTHER SET WAS OPENED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT INJURIES.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 20010948 ↗

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-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-1962-2021 · May 26, 2021 · Terminated
  Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
• 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-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-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-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-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