VAMP PLUS VP2Recalls & reported problems
Edwards Lifesciences LLC · BLOOD MANAGEMENT SYSTEM · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07460691944831), received between Sep 2, 2024 and Jul 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
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, IN THIS PRESSURE MONITORING SET WITH VAMP, TUBING WAS DETACHED FROM ONE OF THE CONNECTORS. ISSUE WAS SOLVED REPLACING WITH A DEVICE FROM DIFFERENT LOT NUMBER. THERE WAS NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHIC INFORMATION UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469762 ↗MalfunctionSep 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING SET UP OF THIS PRESSURE MONITORING SET WITH VAMP, THE ARM MOUNT SAMPLE SITE TUBING WAS DETACHED FROM THE CONNECTOR. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHIC INFORMATION UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20117195 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K181684, K896819. One submission often covers many models, so check the product and lot details in each record.
- Z-0414-2024 · Oct 4, 2023 · Open, ClassifiedTruWave 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 · TerminatedPressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.