TRUWAVE, VAMPRecalls & reported problems across all models
Edwards Lifesciences LLC · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one TRUWAVE, VAMP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 2
We found 19 models of TRUWAVE, VAMP by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2021 and Mar 17, 2026 — classified as 3 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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, 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-0414-2024 · Root cause: Device Design · names 9 of these models · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported TRUWAVE, VAMP problems
Device problems
- Detachment of Device or Device Component16
- Disconnection9
- Obstruction of Flow6
- Break2
- Inaccurate Flow Rate2
- Adverse Event Without Identified Device or Use Problem1
- Contamination1
- High Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Hemorrhage/Blood Loss/Bleeding8
- Embolism/Embolus6
- Insufficient Information2
- Low Blood Pressure/ Hypotension1
- Vasoconstriction1
TRUWAVE, VAMP models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRUWAVE, VAMP PXAVMPCatheter, continuous flush1 recall7 reports
- TruWave, VAMP T001744MTransducer, Pressure, Catheter Tip1 recall6 reports
- TRUWAVE, VAMP PXAVMP3Catheter, continuous flush1 recall2 reports
- TRUWAVE, VAMP PXVMP2X22Catheter, continuous flush1 recall0 reports
- TRUWAVE, VAMP PXVMP3X32Catheter, continuous flush1 recall0 reports
- TRUWAVE, VAMP PXVMP2X21TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE, VAMP PXVK0364Catheter, continuous flush1 recall0 reports
- TRUWAVE, VAMP PXVK0996TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE, VAMP PXVK0853Catheter, continuous flush1 recall0 reports
- TRUWAVE, VAMP PXVK1099TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TRUWAVE, VAMP PXVMP184TRANSDUCER, PRESSURE, CATHETER TIP10 reports
- TRUWAVE, VAMP PXVMP172Catheter, continuous flush3 reports
- TRUWAVE, VAMP PXVMP172AT3Catheter, continuous flush2 reports
- TRUWAVE, VAMP PXVK0670TRANSDUCER, PRESSURE, CATHETER TIP2 reports
- TRUWAVE, VAMP PXVMP160Catheter, continuous flush2 reports
- TRUWAVE, VAMP PXVK1102TRANSDUCER, PRESSURE, CATHETER TIP2 reports
- TRUWAVE, VAMP T001741ATransducer, Pressure, Catheter Tip1 report
- TRUWAVE, VAMP T005048BTransducer, Pressure, Catheter Tip1 report
- TRUWAVE, VAMP PXVMP260TRANSDUCER, PRESSURE, CATHETER TIP1 report
Recent TRUWAVE, VAMP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, IN THIS PRESSURE MONITORING SET WITH VAMP, THE PRESSURE TUBING BROKE NEAR THE VAMP RESERVOIR. THERE WAS NO PATIENT INJURY. AS PER PRODUCT EVALUATION, THE PRESSURE TUBING WAS FOUND COMPLETELY DETACHED FROM THE VAMP RESERVOIR STOPCOCK BOND JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615197 ↗MalfunctionMar 13, 2026Detachment of Device or Device Component
AS REPORTED DURING BLOOD SAMPLING DURING USE ON A PATIENT THE CONNECTION BETWEEN THE PATIENT SIDE THREE WAY STOPCOCK AND THE PLANECTA GOT LOOSENED AND DETACHED, THEN A SMALL AMOUNT OF BLOOD LEAKAGE OCCURRED. WHEN THE DEVICE WAS REPLACED, THE PROBLEM WAS SOLVED. THE PATIENT WAS AN ADULT. NO TRANSFUSION NOR EXTENSION OF HOSPITALIZATION WAS REQUIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR PRODUCT EVALUATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24590294 ↗MalfunctionFeb 13, 2026Detachment of Device or Device Component
AS REPORTED DURING USE THE PRESSURE MONITORING SET HAD BLOOD THAT BACKED UP INTO THE VAMP AND THE RN ATTEMPTED TO APPLY PRESSURE TO THE VAMP PLUNGER TO RETURN THE BLOOD. UPON DOING SO, THE TUBING PROXIMAL TO THE VAMP ON THE PATIENTS SIDE DISCONNECTED AT THE CONNECTION POINT. NO AIR WAS INTRODUCED AND THERE WAS MINIMAL BLOOD LOSS AS THE NURSE WAS PRESENT AT THE TIME OF DISCONNECTION. THE VAMP TUBING WAS CHANGED IMMEDIATELY. THERE WAS NO PATIENT INJURY. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24334256 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING BLOOD SAMPLING WITH THIS PRESSURE MONITORING SET, THE VAMP TUBING DETACHED. THE TUBING COULD NOT BE REASSEMBLED AS IT WAS COMPLETELY DETACHED. IT WAS NOTED THAT THIS ISSUE HAS OCCURRED PREVIOUSLY. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923290 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING BLOOD SAMPLING WITH THIS PRESSURE MONITORING SET, THE VAMP TUBING DETACHED. THE TUBING COULD NOT BE REASSEMBLED AS IT WAS COMPLETELY DETACHED. IT WAS NOTED THAT THIS ISSUE HAS OCCURRED PREVIOUSLY. THERE IS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923169 ↗MalfunctionDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING USE OF THE TRUWAVE, THE PATIENT EXPERIENCED ARTERIAL VASOSPASM. THEY ATTEMPTED TO DRAW SLOWER WITHOUT SUCCESS. THEY ULTIMATELY DREW WASTE AND BLOOD FROM THE NEEDLESS ACCESS PORT SUCCESSFULLY. SUBSEQUENTLY, THEY OBSERVED SIGNIFICANT VASOSPASM OF THE ARTERY. FINALLY, WHEN ATTEMPTING TO USE THE PULL TAB TO FLUSH THE LINE THE TAB BROKE OFF. THERE WAS NO PATIENT INJURY.
Patient problems: Vasoconstriction
MAUDE report 23785790 ↗MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, IN THIS PRESSURE MONITORING SET WITH VAMP ADULT THE ARTERIAL LINE DETACHED FROM THE RESERVOIR CAUSING BLEEDING FOR THE PATIENT. APPARENTLY, THERE WAS NO TUGGING ON THE LINE. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22468644 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING FLUSHING AND AFTER DRAWING A BLOOD SAMPLE, IN THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP, THE PRESSURE TUBING DETACHED FROM THE RESERVOIR. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393190 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING FLUSHING AND AFTER DRAWING A BLOOD SAMPLE, IN THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP, THE PRESSURE TUBING DETACHED FROM THE RESERVOIR. THERE WAS NO BLOOD LOSS. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393066 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING USE OF THE PRESSURE MONITORING SET, WHEN THE RESPIRATORY THERAPIST TOUCHED THE RIGHT RADIAL ARTERIAL LINE TUBING THE TUBING PULLED OUT/BECAME DISCONNECTED FROM THE VAMP AND BLOOD DRAINED ON THE FLOOR. THE RN WAS ABLE TO CLAMP THE LINE AND ATTACH NEW VAMP AND TUBING TO A LINE HUB. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22391816 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE OF THE PRESSURE MONITORING SET, THE ARTERIAL LINE WAS SUSPECTED TO HAVE BEEN PULLED BY THE PATIENT. HOWEVER, WHEN APPLYING PRESSURE TO STOP BLEEDING IT WAS NOTED THAT CATHETER WAS STILL IN PLACE IN THE ARTERY, DESPITE A LACK OF SUTURES AND ONLY HELD IN PLACE BY A STANDARD TRANSPARENT DRESSING. PER THE CUSTOMER, IT APPEARED THAT ARTERIAL TUBING SEPARATED FROM LUERLOCK CONNECTION, LEAVING THE CATHETER AND LUERLOCK IN PLACE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22391798 ↗MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS DISPOSABLE PRESSURE TRANSDUCER PRESSURE TUBING DETACHED NEAR THE VAMP SYSTEM. THERE WAS 2 ML OF BLOOD LOSS. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS REPLACED WITH A NEW UNIT. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22381340 ↗MalfunctionMay 14, 2025Disconnection; Disconnection
AS REPORTED DURING PRIMING AT THE ME CENTER AND BEFORE USE IN A PATIENT THE CONNECTIONS OF THE PRESSURE MONITORING KIT GOT DISCONNECTED BETWEEN THE DPT ROTATE PART AND THREE WAY ZERO STOPCOCK. TIGHTENING THE CONNECTION DID NOT FIX THE ISSUE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL NOT BE AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22020825 ↗MalfunctionMay 14, 2025Disconnection; Disconnection
AS REPORTED DURING PRIMING AT THE ME CENTER AND BEFORE USE IN A PATIENT THE CONNECTIONS OF THE PRESSURE MONITORING KIT GOT DISCONNECTED BETWEEN THE DPT ROTATE PART AND THREE WAY ZERO STOPCOCK. TIGHTENING THE CONNECTION DID NOT FIX THE ISSUE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22020787 ↗MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING PREPARATION BEFORE USE OF THIS PRESSURE MONITORING SET WITH VAMP, THE PRESSURE TUBING DETACHED FROM THE CONNECTION TO RESERVOIR. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21891699 ↗
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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