VAMP 48VMP120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07460691951792), received between Jul 28, 2021 and Jul 28, 2021 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE USING THIS VAMP AFTER INSERTING AN ARTERIAL LINE, THE TUBING SEPARATED FROM CONNECTOR LUER LOCK AT THE END CLOSEST TO THE PATIENT. THE PATIENT WAS NOT A PEDS PATIENT. IT WAS A (B)(6) YEARS OLD FEMALE WITH AN ACUTE STROKE IN THE ICU. THERE WAS MINIMAL BLOOD LOSS BUT NO INJURY TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12239378 ↗

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