TRUWAVE, VAMP PLUS PXVP0550Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07460691949911), received between Dec 19, 2023 and May 8, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 reports).

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

11 other recalls cover devices cleared under the same FDA submission (K142749, K181684, 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. How this data works · Data updated Oct 13, 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-0414-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT DURING USE OF THE TRUWAVE, THE NURSE NOTICED THAT THE PRESSURE BAG FOR THE 3-WAY PRESSURE INFUSING TUBING HAD BEEN CHANGED TWO TIMES SINCE PATIENT HAD GOTTEN BACK FROM HEART SURGERY AT 13: 00. AFTER INVESTIGATING, THE NURSE FOUND THAT CVP HAD A SLOW LEAK AND PATIENT HAD BEEN RECEIVING THE FLUIDS OVER THE COURSE OF ONE AND A HALF SHIFTS. CHANGED TUBING AND THE ISSUE RESOLVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123479 ↗
• MalfunctionMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED DURING USE IN A PATIENT WITH THIS PRESSURE MONITORING KIT THE CONNECTION BETWEEN THE Z SITE SAMPLING SITE AND PRESSURE TUBING WAS FOUND DETACHED. THIS OCCURRED WHEN THE PATIENT POSTURE WAS BEING ADJUSTED AFTER REHABILITATION. THERE WAS ALSO BACKFLOW OF BLOOD INTO THE ARTERIAL LINE. WHEN THESE MALFUNCTIONS WERE FOUND THERE WAS NO STRONG TENSION ON THE KIT. THE CUSTOMER COMMENTED IT WAS POSSIBLE THAT SOME PRESSURE HAD BEEN APPLIED DURING REHABILITATION. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022477 ↗
• MalfunctionDec 19, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE CUSTOMER IS UNABLE TO ZERO THE TRANSDUCERS. THE CUSTOMER WILL ATTEMPT TO ZERO THE TRANSDUCER ON THEIR PHILIPS MONITOR AND EITHER WILL NOT GET A ZERO OR THE MONITOR WILL SHOW A QUESTION MARK IN THE NUMERIC SPOT WITH A FLAT WAVE LINE. THE CUSTOMER STATED THAT THEY WILL CHANGE THE DPT AND THE ISSUE TYPICALLY RESOLVES. THERE WAS NO ALLEGATION OF PATIENT INJURY. TWO SEPARATE EVENTS OCCURRED ON 11/30. EVENTS OCCURRED DURING SETUP. TROUBLESHOOTING INCLUDED SWAPPED CABLES AND MONITOR MODULES. LASTLY SWAPPED TRANSDUCER SETUP AND EVERYTHING FUNCTIONED. THERE WAS NO PATIENT INJURY. PRODUCTS ARE AVAILABLE FOR RETURN. THE PA LINE ON 1 UNIT HAS SMALL PIECE OF UNKNOWN OBJECT IN THE MIDDLE OF THE LINE. PRODUCTS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354845 ↗
• MalfunctionDec 19, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE CUSTOMER IS UNABLE TO ZERO THE TRANSDUCERS. THE CUSTOMER WILL ATTEMPT TO ZERO THE TRANSDUCER ON THEIR PHILIPS MONITOR AND EITHER WILL NOT GET A ZERO OR THE MONITOR WILL SHOW A QUESTION MARK IN THE NUMERIC SPOT WITH A FLAT WAVE LINE. THE CUSTOMER STATED THAT THEY WILL CHANGE THE DPT AND THE ISSUE TYPICALLY RESOLVES. THERE WAS NO ALLEGATION OF PATIENT INJURY. TWO SEPARATE EVENTS OCCURRED ON 11/30. EVENTS OCCURRED DURING SETUP. TROUBLESHOOTING INCLUDED SWAPPED CABLES AND MONITOR MODULES. LASTLY SWAPPED TRANSDUCER SETUP AND EVERYTHING FUNCTIONED. THERE WAS NO PATIENT INJURY. PRODUCTS ARE AVAILABLE FOR RETURN. THE PA LINE ON 1 UNIT HAS SMALL PIECE OF UNKNOWN OBJECT IN THE MIDDLE OF THE LINE. PRODUCTS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354580 ↗
• MalfunctionDec 19, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE CUSTOMER IS UNABLE TO ZERO THE TRANSDUCERS. THE CUSTOMER WILL ATTEMPT TO ZERO THE TRANSDUCER ON THEIR PHILIPS MONITOR AND EITHER WILL NOT GET A ZERO OR THE MONITOR WILL SHOW A QUESTION MARK IN THE NUMERIC SPOT WITH A FLAT WAVE LINE. THE CUSTOMER STATED THAT THEY WILL CHANGE THE DPT AND THE ISSUE TYPICALLY RESOLVES. THERE WAS NO ALLEGATION OF PATIENT INJURY. TWO SEPARATE EVENTS OCCURRED ON 11/30. EVENTS OCCURRED DURING SETUP. TROUBLESHOOTING INCLUDED SWAPPED CABLES AND MONITOR MODULES. LASTLY SWAPPED TRANSDUCER SETUP AND EVERYTHING FUNCTIONED. THERE WAS NO PATIENT INJURY. PRODUCTS ARE AVAILABLE FOR RETURN. THE PA LINE ON 1 UNIT HAS SMALL PIECE OF UNKNOWN OBJECT IN THE MIDDLE OF THE LINE. PRODUCTS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354562 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142749, K181684, 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-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-1962-2021 · May 26, 2021 · Terminated
  Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
• 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-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-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-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-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