FLOTRAC, VAMP, TRUWAVE MHD6C502Recalls & reported problems

Edwards Lifesciences LLC · FLOTRAC SENSOR WITH VAMP SYSTEM · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103194760), received between Feb 24, 2025 and Feb 24, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K131588, K131892, K152980); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Oct 4, 2023Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Device problems

Detachment of Device or Device Component2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, WHEN THE FLOTRAC WAS REMOVED FROM THE PACKAGING, THE TUBING CAME OFF THE STOPCOCK WITH MINIMAL MANIPULATION. NO TROUBLESHOOTING WAS ATTEMPTED AS THE TUBING CAME APART DURING SET UP. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447006 ↗
MalfunctionFeb 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, WHEN THE FLOTRAC WAS REMOVED FROM THE PACKAGING, THE TUBING CAME OFF THE STOPCOCK WITH MINIMAL MANIPULATION. NO TROUBLESHOOTING WAS ATTEMPTED AS THE TUBING CAME APART DURING SET UP. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446949 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131588, K131892, K152980. One submission often covers many models, so check the product and lot details in each record.

Z-0410-2024 · Oct 4, 2023 · Open, Classified
Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Z-0411-2024 · Oct 4, 2023 · Open, Classified
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Z-0409-2024 · Oct 4, 2023 · Open, Classified
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.

Device details

UDI-DI	`00690103194760`
Brand	FLOTRAC, VAMP, TRUWAVE
Model	MHD6C502
Company	Edwards Lifesciences LLC
Product code	DXG · COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
Class	Class 2
FDA submission	K131588, K131892, K152980
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Invasive-pressure external transducer, single-use

A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.

Other COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION devices

FLOTRAC MHD8
Edwards Lifesciences LLC · COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
1 recall5 reports
FLOTRAC, VAMP MHD6AZ
Edwards Lifesciences LLC · COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
1 recall4 reports
FLOTRAC, VAMP MHD6AZ5
Edwards Lifesciences LLC · COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
1 recall1 report
SWAN-GANZ 70CC2
Edwards Lifesciences LLC · COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
4 reports
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER X3820ST
Edwards Lifesciences LLC · COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
2 reports
EV1000 EV1000A
Edwards Lifesciences LLC · COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
2 reports
ICU Medical 58400-000
Icu Medical, Inc. · COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
1 report
FLOTRAC MHD65
Edwards Lifesciences LLC · COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
1 report

All COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page