FLOTRAC, VAMPRecalls & reported problems across all models
Edwards Lifesciences LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one FLOTRAC, VAMP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of FLOTRAC, VAMP by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2019 and Sep 18, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
FLOTRAC, VAMP recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 4, 2023Open, Classified
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Z-0412-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported FLOTRAC, VAMP problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings4
- Loose or Intermittent Connection1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Information1
FLOTRAC, VAMP models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FLOTRAC, VAMP MHD6AZCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION1 recall4 reports
- FLOTRAC, VAMP MHD6AZ5COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION1 recall1 report
Recent FLOTRAC, VAMP adverse event reports
The 5 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED DURING USE THAT MHD6AZ5 FLOTRAC SENSOR WITH VAMP ADULT WAS USED ON A PATIENT AND THE DIASTOLIC WAS IN THE 20S ON THE A LINE BUT THE UPPER ARM CUFF DIASTOLIC WAS IN THE 70 TO 80S. THE WAVEFORM WAS PERFECT ON THE A LINE AND THE SQUARE WAVE TEST WAS GOOD. THEY RE ZEROED AND NOTHING CHANGED SO THEY DECIDED TO CHANGE OUT THE TRANSDUCER COMPLETELY AND IT MATCHED THE NIBP CUFF RIGHT AWAY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252181 ↗MalfunctionOct 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT A FLOTRAC DEVICE HAD INACCURATE BLOOD PRESSURE VALUES. FLOTRAC WAS ATTACHED TO A HEMOSPHERE AND NON EDWARDS BEDSIDE MONITOR, GE HEALTHCARE. CLINICIAN NOTED THAT THE FLOTRAC DISPLAYED UNEXPECTED SPIKES IN THE BLOOD PRESSURE READINGS. EXCHANGING THE DEVICE RESOLVED THE ISSUE. NO PATIENT INJURIES. USED DEVICE WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17970721 ↗MalfunctionOct 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT A FLOTRAC DEVICE HAD INACCURATE BLOOD PRESSURE VALUES. FLOTRAC WAS ATTACHED TO A HEMOSPHERE AND NON EDWARDS BEDSIDE MONITOR, GE HEALTHCARE. CLINICIAN NOTED THAT THE FLOTRAC DISPLAYED UNEXPECTED SPIKES IN THE BLOOD PRESSURE READINGS. EXCHANGING THE DEVICE RESOLVED THE ISSUE. NO PATIENT INJURIES. USED DEVICE WAS DISCARDED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17970695 ↗MalfunctionOct 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT A FLOTRAC DEVICE HAD INACCURATE BLOOD PRESSURE VALUES. FLOTRAC WAS ATTACHED TO A HEMOSPHERE AND NON EDWARDS BEDSIDE MONITOR, GE HEALTHCARE. CLINICIAN NOTED THAT THE FLOTRAC DISPLAYED UNEXPECTED SPIKES IN THE BLOOD PRESSURE READINGS. EXCHANGING THE DEVICE RESOLVED THE ISSUE. NO PATIENT INJURIES. USED DEVICE WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17970672 ↗MalfunctionMar 19, 2019Material Fragmentation; Loose or Intermittent Connection
THE END OF DEVICE WHERE THE STOPCOCK IS LOCATED WAS "WOBBLY". NURSE UNSCREWED IT FROM THE WHITE RECTANGULAR PORTION AND BITS OF PLASTIC FELL OUT.
Patient problems: No Information
MAUDE report 8431573 ↗
Other Edwards Lifesciences LLC products
- Edwards SAPIEN 315 models · 6,905 reports · 1 recall
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
- INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
- EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
- SAPIEN 3 Ultra RESILIA4 models · 881 reports
- SAPIEN 3 Ultra System3 models · 876 reports
- FOGARTY32 models · 486 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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