VAMP 48VMP106Recalls & 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 07460691959415), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionFeb 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
EDWARDS LIFESCIENCES WAS NOTIFIED VIA A DIRECT VOLUNTARY INCIDENT REPORT SUBMISSION TO THE FDA THAT A CUSTOMER EXPERIENCED, WHEN CHANGING THE ARTERIAL LINE TUBING, A LEAK WITHIN A NEW VAMP. THIS LEAK CAUSE A BACK FLOW OF BLOOD INTO THE LINE MAKING THE PRESSURE INACCURATE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE VOLUNTARY INCIDENT REPORT DID NOT INCLUDE CUSTOMER CONTACT INFORMATION, PATIENT INFORMATION OR PRODUCT INFORMATION RELATED TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21376263 ↗
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, 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
Other Catheter, continuous flush devices
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- MarathonTM 105-5056Micro Therapeutics, Inc. · Catheter, continuous flush124 reports
- Renegade™ HI-FLO™ Kit M001183020Boston Scientific Corporation · Catheter, continuous flush109 reports
- MarksmanTM FA-55150-1030Micro Therapeutics, Inc. · Catheter, continuous flush109 reports
- EkoSonic® 6779-002Boston Scientific Corporation · Catheter, Continuous Flush1 recall4 deaths56 reports
- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.