VAMP PLUS VP0753Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07460691955578), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

2 other recalls cover devices cleared under the same FDA submission (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.

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.

• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Air/Gas in Device; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  EDWARDS LIFESCIENCES WAS NOTIFIED VIA A DIRECT VOLUNTARY INCIDENT REPORT SUBMISSION TO THE FDA THAT A PATIENT EXPERIENCED AIR EMBOLISM ISSUE. THE VOLUNTARY INCIDENT REPORT DID NOT INCLUDE CUSTOMER CONTACT INFORMATION, PATIENT INFORMATION OR PRODUCT INFORMATION RELATED TO THE REPORTED EVENT. A TRUWAVE VAMP PLUS DEVICE WAS INVOLVED. AN ICU PATIENT WAS ASSISTED OUT OF BED INTO A CHAIR, THEN TO THE BEDSIDE COMMODE. THEN ASSISTED BACK TO THE CHAIR BY THE NURSING STAFF. A LEFT RADIAL ARTERIAL LINE WAS IN PLACE, WHICH WAS NOT ACCESSED OR MANIPULATED WHILE THE PATIENT WAS UP. ON TRANSFERRING THE PATIENT BACK TO THE CHAIR, THEY COMPLAINED OF DIZZINESS AND BECAME HYPOTENSIVE AND HAD A CHANGE IN MENTAL STATUS. AN EXISTED LEFT FOREARM PERIPHERAL IV SITE WAS ACCESSED, LACTATED RINGERS HUNG UTILIZING A PRESSURE BAG. THE PATIENT WAS LIFTED BACK TO BED AND BECAME BRADYCARDIC WITH CYANOSIS FROM THE NECK UP. CPR WAS BEGUN AND THE PATIENT WAS INTUBATED WITH ROSC TO A BRADYCARDIC PULSE IN TWO MINUTES. A CENTRAL LINE WAS PLACED AT THE RIGHT GROIN. FLUIDS WERE INFUSED VIA AN IV PUMP. A CARDIAC ELECTROCARDIOGRAM WAS COMPLETED FOLLOWING CARDIAC ARREST. THERE WERE NOTED BUBBLES SEEN IN THE RIGHT ATRIUM AND

  Patient problems: Air Embolism

  MAUDE report 21413012 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K896819. 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-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