TRUWAVERecalls & reported problems across all models
Edwards Lifesciences LLC · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one TRUWAVE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 1
We found 34 models of TRUWAVE by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2023 and Sep 30, 2026 — classified as 7 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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
TRUWAVE 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-0413-2024 · Root cause: Device Design · names 23 of these models · Recall details · FDA record ↗
Most reported TRUWAVE problems
Device problems
- Detachment of Device or Device Component13
- Contamination12
- Incorrect Measurement8
- Delivered as Unsterile Product4
- Inaccurate Delivery4
- Incorrect, Inadequate or Imprecise Result or Readings4
- Low Readings4
- Fluid/Blood Leak3
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- Burn(s)2
- Hemorrhage/Blood Loss/Bleeding2
- High Blood Pressure/ Hypertension2
- Hypervolemia2
- Unspecified Respiratory Problem2
- Weight Changes2
- Air Embolism1
TRUWAVE models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRUWAVE PX260TRANSDUCER, PRESSURE, CATHETER TIP1 recall29 reports
- TRUWAVE PXMK2041TRANSDUCER, PRESSURE, CATHETER TIP1 recall4 reports
- TRUWAVE PX284TRANSDUCER, PRESSURE, CATHETER TIP1 recall3 reports
- TRUWAVE T001709ATransducer, Pressure, Catheter Tip1 recall1 report
- TRUWAVE PX2X2TRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE PX272TRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE PX212TRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE PX3X3284CTRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE T001657ATransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE T001658ATransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE T001660ATransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE T321573ATransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE T433803ATransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE T441T01CTransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE PX600FTRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE T494C00BTransducer, Pressure, Catheter Tip1 recall0 reports
- TRUWAVE PX4X4TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PXMK1876TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PXMK9146TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PXMK1940TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PXMK2024TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PXMK2321TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PXMK2331TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE PX600ITRANSDUCER, PRESSURE, CATHETER TIP3 reports
- TRUWAVE PX284ANTRANSDUCER, PRESSURE, CATHETER TIP2 reports
- TRUWAVE PX200TRANSDUCER, PRESSURE, CATHETER TIP2 reports
- TRUWAVE MK2220TRANSDUCER, PRESSURE, CATHETER TIP1 report
- TRUWAVE PX1800TRANSDUCER, PRESSURE, CATHETER TIP1 report
- TruWave PXVPZ10025Transducer, Pressure, Catheter Tip1 report
- TRUWAVE PX36NTRANSDUCER, PRESSURE, CATHETER TIP1 report
- TRUWAVE PX12NTRANSDUCER, PRESSURE, CATHETER TIP1 report
- TRUWAVE 58K16906TRANSDUCER, PRESSURE, CATHETER TIP1 report
- TRUWAVE PXMK1085TRANSDUCER, PRESSURE, CATHETER TIP1 report
- TRUWAVE PX600TRANSDUCER, PRESSURE, CATHETER TIP1 report
Recent TRUWAVE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951164 ↗MalfunctionApr 7, 2026Detachment of Device or Device Component
AS REPORTED DURING USE THE PRESSURE MONITORING SET TRANSDUCER DISCONNECTED SPONTANEOUSLY AND CSF (CEREBROSPINAL FLUID) WAS LEAKING OUT OF IT. THE NURSE CHANGED OUT THE TRANSDUCER PER PROTOCOL. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS CONTAMINATED AND PICKED UP BY ANOTHER COMPANY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801323 ↗MalfunctionApr 7, 2026Detachment of Device or Device Component
AS REPORTED DURING USE THE PRESSURE MONITORING SET TRANSDUCER FELL OFF ONTO THE FLOOR WHEN A PATIENT WAS UNDERGOING AN EXTERNAL VENTRICULAR DRAIN. THE EVD WAS ALREADY CLAMPED, SO THE PATIENT REMAINED SAFE. A NEW TRANSDUCER WAS APPLIED STERILE PER PROTOCOL. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS CONTAMINATED AND PICKED UP BY ANOTHER COMPANY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801145 ↗MalfunctionMar 31, 2026Contamination
AS REPORTED, THIS DISPOSABLE PRESSURE TRANSDUCER TUBING HAD BLACK UNKNOWN SUBSTANCES INSIDE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741442 ↗MalfunctionMar 26, 2026Incorrect Measurement
AS REPORTED, THIS PRESSURE MONITORING SET DISPLAYED INACCURATE PRESSURE VALUES OF 0.2. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE PRESSURE VALUES PROVIDED, AND THE VALUES WERE NOT COMPARED WITH ANOTHER SOURCE. THERE IS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24708192 ↗MalfunctionMar 26, 2026Contamination
AS REPORTED, DURING USE IN PATIENT, INSPECTION OF THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) REVEALED THAT THE FEMALE LUER ON THE DPT HOUSING, WHICH CONNECTS TO THE IV TUBING, WAS BLOCKED BY A FOREIGN MATERIAL. THE PROBLEM WAS SOLVED BY REPLACING THE DEVICE WITH A NEW ONE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698083 ↗MalfunctionMar 26, 2026Low Readings
AS REPORTED, AFTER CONNECTING THIS PRESSURE MONITORING SET TO THE PATIENT'S RADIAL ARTERY, THE PRESSURE VALUES OBTAINED (75/47 MMHG) DIFFERED SIGNIFICANTLY FROM THE PREOPERATIVE NON-INVASIVE CUFF MEASUREMENT (135/85 MMHG). NO ABNORMAL ALARMS OR ALERTS WERE OBSERVED. THE PRESSURE MONITORING SET WAS REPLACED WITH A NEW UNIT, AFTER WHICH NORMAL PRESSURE READINGS (143/88 MMHG) WERE OBTAINED. THE PATIENT DID NOT RECEIVE ANY TREATMENT BASED ON THE INACCURATE READINGS. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698026 ↗MalfunctionMar 25, 2026Low Readings
AS REPORTED, DURING SET-UP OF THIS DISPOSABLE PRESSURE TRANSDUCER (DPT), THE CARDIAC OUTPUT (CO) VALUE DISPLAYED WAS 1.1 L/MIN WHEREAS THE EXPECTED VALUE ACCORDING TO PATIENT CONDITION WAS 5 L/MIN. NO ERROR MESSAGE WAS DISPLAYED. THE PATIENT WAS NOT TREATED BASED ON INCORRECT VALUES. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS INFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24685276 ↗InjuryMar 9, 2026Low Readings
AS REPORTED, DURING USE IN AN INTENSIVE CARE PATIENT WITH DISSEMINATED INTRAVASCULAR COAGULATION (DIC), THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) CONNECTED TO THE RADIAL CATHETER, DISPLAYED AN ABNORMALLY LOW BLOOD PRESSURE VALUE. CONSEQUENTLY, THE PATIENT WAS TREATED WITH A HIGH DOSE OF VASOPRESSORS AS FLUID RESUSCITATION. SINCE THE VALUES DID NOT CHANGE AFTER ADMINISTERING MEDICATION, ANOTHER PRESSURE SENSOR WAS CONNECTED TO THE FEMORAL VEIN, WHICH SHOWED PRESSURE VALUES 10MMHG HIGHER, CONSIDERED CORRECT AS PER PATIENT CONDITION. ALSO A CUFF WAS CONNECTED AND SHOWED PRESSURE VALUES WHICH WERE IN BETWEEN THE RADIAL AND THE FEMORAL VALUES AND WERE ALSO CONSIDERED TO BE CORRECT. THERE WAS NO ERROR MESSAGE DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: High Blood Pressure/ Hypertension
MAUDE report 24544725 ↗InjuryMar 9, 2026Low Readings
AS REPORTED, DURING USE IN AN INTENSIVE CARE PATIENT WITH DISSEMINATED INTRAVASCULAR COAGULATION (DIC), THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) CONNECTED TO THE RADIAL CATHETER, DISPLAYED AN ABNORMALLY LOW BLOOD PRESSURE VALUE. THERE WAS NO ERROR MESSAGE DISPLAYED. CONSEQUENTLY, THE PATIENT WAS TREATED WITH A HIGH DOSE OF VASOPRESSORS AS FLUID RESUSCITATION. SINCE THE VALUES DID NOT CHANGE 3 HOURS AFTER ADMINISTERING THE MEDICATION, ANOTHER PRESSURE SENSOR WAS CONNECTED TO THE FEMORAL VEIN, WHICH SHOWED PRESSURE VALUES CONSIDERED TO BE CORRECT OF 197MMHG/68MMHG. THE DPT SHOWED PRESSURE VALUES OF 131MMHG/59MM HG. ALSO, A CUFF WAS CONNECTED AND SHOWED PRESSURE VALUES WHICH WERE IN BETWEEN THE RADIAL AND THE FEMORAL VALUES AND WERE ALSO CONSIDERED TO BE CORRECT. DECREASING THE AMINES LED TO PATIENT IMPROVEMENT, AND THE VALUES FROM THE FEMORAL SENSOR SEEMED COHERENT WITH PATIENT CONDITION. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: High Blood Pressure/ Hypertension
MAUDE report 24544585 ↗InjuryMar 3, 2026Inaccurate Delivery
AS REPORTED, DURING USE IN A NEONATAL PATIENT, THIS PRESSURE MONITORING KIT ADMINISTRATED TOO MUCH FLUID BECAUSE OF HIGHER FLOW RATE: FROM 0.2 TO 0.3 CC/HOUR. THE VOLUME OF SALINE ADMINISTRATED OVER 48 HOURS WAS ABOUT 120ML. ALL THE CONNECTIONS WERE CORRECTLY MADE. THEN, IT WAS DECIDED TO REMOVE THE UMBILICAL CATHETER. THE PATIENT HAD AN ELECTROLYTE IMBALANCE, GAINED TOO MUCH WEIGHT, AND SUFFERED A RESPIRATORY DEGRADATION. UNKNOWN MEDICATION WAS PROVIDED FOR IONIC REBALANCING. THE DEVICE WAS AVAILABLE FOR EVALUATION.
Patient problems: Hypervolemia; Unspecified Respiratory Problem; Weight Changes
MAUDE report 24494587 ↗MalfunctionMar 2, 2026Contamination
AS REPORTED, THIS NEWLY OPENED DISPOSABLE PRESSURE TRANSDUCER (DPT) HAD VISIBLE BLACK STAINS INSIDE THE DRIP CHAMBER. THE PROBLEM WAS SOLVED BY REPLACING THE DEVICE WITH A NEW ONE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481196 ↗InjuryFeb 18, 2026Inaccurate Flow Rate; Inaccurate Delivery
AS REPORTED, SEVERAL TIMES DURING 7 DAYS OF USE IN A PREMATURE BABY, THIS DISPOSABLE PRESSURE TRANSDUCER GOT DEPRESSURIZED CAUSING BACK FLOW AND A FLAT BLOOD PRESSURE CURVE. THE SYSTEM WAS FLUSHED AND PRESSURIZED EVERY TIME THE PROBLEM OCCURRED A PART FROM THE DAILY SYSTEM CHECKS. THE SYSTEM PRESSURE HAD TO BE ADJUSTED SEVERAL TIMES A DAY, WHICH IS UNUSUAL. ONE OF THE TIMES, THE SALINE BAG WAS NOTICED EMPTY. THIS MEANS THAT THE CHILD SHOULD HAVE RECEIVED 336 ML OVER 7 DAYS AND THAT THE ENTIRE 1-LITER BAG HAS BEEN CONSUMED. THE ENTIRE SYSTEM WAS REPLACED. THE CONSEQUENCES FOR THE PATIENT WERE ELECTROLYTE IMBALANCES, FAILURE TO INSERT A CENTRAL VENOUS CATHETER DUE TO EXCESSIVE LYMPHATIC FLUID, RESPIRATORY DIFFICULTIES WITH DELAYED EXTUBATING AND GAINED UP TO 310G BY DAY 4. THE PATIENT WAS TREATED WITH ANTIDIURETICS (LASILIX) AND HE IS OKAY.
Patient problems: Hypervolemia; Unspecified Respiratory Problem; Weight Changes
MAUDE report 24375460 ↗MalfunctionFeb 17, 2026Detachment of Device or Device Component
AS REPORTED, BEFORE USE IN PATIENT, THIS DISPOSABLE PRESSURE TRANSDUCER HAD A BROKEN LUER CONNECTION. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER EVALUATION RESULTS, PRESSURE TUBING WAS FOUND COMPLETELY DETACHED FROM BOND JOINT WITH PROXIMAL MALE CONNECTOR. PATIENT DEMOGRAPHIC INFORMATION UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24365123 ↗MalfunctionFeb 5, 2026Contamination
AS REPORTED, DURING FLUSHING OF THIS PRESSURE MONITORING SET PRIOR TO PATIENT CONNECTION, A BLACK FLOCCULENT MATERIAL WAS OBSERVED INSIDE OF ONE TUBING. THERE WAS NO PATIENT INVOLVEMENT, SINCE THE ISSUE WAS DETECTED DURING THE PREPARATION STAGE IN THE PREPARATION ROOM. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, AS IT WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24267969 ↗
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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