VAMP 48VMP160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07460691950610), received between Dec 10, 2024 and May 9, 2025 — classified as 2 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K173586, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT OF THIS PRESSURE MONITORING SET WITH VAMP, THERE WAS BLOOD AND SALINE LEAKAGE FROM THE RESERVOIR. THE BLOOD LOSS WAS MINIMAL AND NO BLOOD TRANSFUSION WAS REQUIRED. THE ISSUE WAS SOLVED REPLACING WITH A NEW UNIT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER EVALUATION RESULTS, PRESSURE TUBING WAS COMPLETELY DETACHED FROM BOND JOINT WITH VAMP ADULT RESERVOIR STOPCOCK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21992850 ↗
• MalfunctionDec 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, AFTER ARTERIAL BLOOD DRAW FOR BLOOD GAS TESTING WITH THIS VAMP SYSTEM, THE SAMPLING SITE SEPTUM SLIPPED INTO THE TUBING CAUSING BLOOD LEAKAGE. THE BLOOD LEAKAGE WAS MINIMAL AND NO ADDITIONAL INTERVENTION WAS NEEDED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20890460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173586, 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