VAMP JR. VMP306Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07460691944787), received between Aug 14, 2025 and Dec 8, 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 (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.

• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHILE PURGING THIS VAMP JR TO CONNECT IT TO THE CENTRAL VENOUS LINE, A LEAKAGE IN THE MIDDLE OF THE LINE AT A SOLDERED CONNECTION WAS NOTICED. AT THE MOMENT OF REPLACING THE DEVICE FOR ANOTHER ONE, THE LEAKING TUBING DETACHED. AS PER CUSTOMER'S OPINION, THERE IS POTENTIAL RISK OF AIR EMBOLISM, HEMORRHAGE, AND INFECTION IF THE LEAK IS NOT IMMEDIATELY DETECTED. THERE WAS PROLONGED PROCEDURE TIME AND NO PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741839 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE VAMP JR., IT BROKE FROM WITHIN THE DRAWING MECHANISM DURING A BLOOD DRAW CAUSING PROMPT CHANGE OF ARTERIAL LINE SET UP. WHEN PULLING UP ON THE VAMP JR. PLUNGER, THE PLUNGER BECAME DETACHED FROM THE TUBING SET AND BEGAN SUCKING IN AIR. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808924 ↗

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