TRUWAVE, VAMP PXVK0670Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07460691954748), received between May 7, 2024 and Jul 10, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

12 other recalls cover devices cleared under the same FDA submission (K142749, 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 18, 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.

• MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, IN THIS PRESSURE MONITORING SET WITH VAMP ADULT THE ARTERIAL LINE DETACHED FROM THE RESERVOIR CAUSING BLEEDING FOR THE PATIENT. APPARENTLY, THERE WAS NO TUGGING ON THE LINE. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22468644 ↗
• MalfunctionMay 7, 2024Incorrect Measurement; High Readings; Incorrect Measurement; High Readings

  AS REPORTED, DURING USE IN PATIENT WITH THIS DISPOSABLE PRESSURE TRANSDUCER, THE ARTERIAL LINE WAS SHOWING A MEAN ARTERIAL PRESSURE (MAP) OF 100 MMHG. NO ALARMS OR ERROR MESSAGES WERE DISPLAYED. MANUAL BLOOD PRESSURE WAS DONE WITH A VERY CLEAR 70/40 MMHG WITH A MAP EQUALING 50. ARTERIAL LINE RE ZEROED, CHECKED PRESSURE BAG, CHECKED CANNULA FOR KINKS, ENSURED TRANSDUCER WAS IN CORRECT PLACE AND GOT A NEW CABLE. STILL SHOWING A BLOOD PRESSURE WITH A MAP OF 100. NEW TRANSDUCER LINE PRIMED AND CONNECTED, SHOWING AN ACCURATE BLOOD PRESSURE WITH A MAP OF APPROXIMATELY 50 MMHG. BLOOD PRESSURE WAS TREATED ACCORDINGLY. AS PER CUSTOMER OPINION, THE INACCURATE VALUE ISSUE RESULTED IN AN EXTENDED PERIOD OF PATIENT HYPOTENSION WHICH COULD CAUSE A PATIENT INJURY, THEREFORE THIS WAS REPORTED AS AN INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 19258525 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142749, K896819. 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-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-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-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-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
• 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