Skip to content

VAMP Jr VJ0095Recalls & reported problems

Edwards Lifesciences LLC · Blood Management System · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103199666), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 malfunction.

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Air/Gas in Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 8, 2026Air/Gas in Device

    AS REPORTED DURING USE A VAMP JR HAD AIR BUBBLES. NO ADDITIONAL INFORMATION WAS AVAILABLE AFTER CUSTOMER FOLLOW-UP. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24015197 ↗

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

Other Catheter, Continuous Flush devices

All Catheter, Continuous Flush devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.