TRUWAVE PX2X2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07460691950061), received between Aug 9, 2024 and Aug 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

10 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.

Recalls naming this device

1. Oct 4, 2023Open, Classified

   Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

   Z-0413-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, BEFORE USE IN PATIENT WITH THIS DISPOSABLE PRESSURE TRANSDUCER (DPT), THE PACKAGE WAS DAMAGED, AND THE STOPCOCK SCREW WAS MISSING. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949267 ↗

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-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-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-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-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-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-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