TruWave, VAMP Plus PXVPL2284Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103200348), received between Mar 24, 2023 and Mar 29, 2023 — classified as 2 injuries.

11 other recalls cover devices cleared under the same FDA submission (K141495, K142749, K161962, K183413); 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 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THIS VESICLE ASSOCIATED MEMBRANE PROTEIN (VAMP) SYSTEM (MODEL PXVPL2284, LOT 64598033), AFTER DRAWING AN ARTERIAL BLOOD GAS (ABG) AND FLUSHING THE DEVICE TO CLEAR THE VOLUME, THE 31 YEAR OLD MALE PATIENT HAD A CHANGE IN MENTAL STATUS. THE PATIENT BECAME UNRESPONSIVE, NOT RESPONDING TO VERBAL OR NOXIOUS STIMULI, AND NOT MOVING EXTREMITIES. THE ACUTE STROKE TEAM WAS CALLED AND BRAIN IMAGING WAS NOTABLE FOR PNEUMOCEPHALUS IN RIGHT PARIETO-OCCIPITAL REGION. THE TROUBLESHOOTING IS UNKNOWN. THE CAREGIVER DID NOT SEE ANY AIR BUBBLES IN THE LINE BUT IT WAS REPORTED THAT THE PATIENT SUFFERED AN AIR EMBOLISM AND WAS UNRESPONSIVE WITH RIGHT SIDE DEFICIT.

  Patient problems: Air Embolism

  MAUDE report 16637597 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem

  DURING USE OF VESICLE ASSOCIATED MEMBRANE PROTEIN (VAMP) SYSTEM, AN ARTERIAL BLOOD GAS WAS DRAWN. AFTER FLUSHING THE DEVICE TO CLEAR THE VOLUME THE PATIENT HAD A CHANGE IN MENTAL STATUS. PATIENT BECAME UNRESPONSIVE, NOT RESPONDING TO VERBAL OR NOXIOUS STIMULI, AND NOT MOVING EXTREMITIES. ACUTE STROKE TEAM WAS CALLED. BRAIN IMAGING NOTABLE FOR PNEUMOCEPHALUS IN RIGHT PARIETO-OCCIPITAL REGION. MANUFACTURER RESPONSE FOR TRANSDUCER, PRESSURE, CATHETER TIP, TRUWAVE, VAMP PLUS (PER SITE REPORTER). MANUFACTURER IS COMPLETING INTERNAL TESTING TO TEST SYSTEM.

  Patient problems: Altered State of Consciousness; Pneumocephalus

  MAUDE report 16609724 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141495, K142749, K161962, K183413. 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-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-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-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-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-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-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