TRUWAVE, VAMP PLUSRecalls & reported problems across all models
Edwards Lifesciences LLC · 17 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, VAMP PLUS 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
- 5
- Recalls
- 1
We found 17 models of TRUWAVE, VAMP PLUS 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 Dec 9, 2019 and May 8, 2026 — classified as 5 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Contamination” (10 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, VAMP PLUS 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 12 of these models · Recall details · FDA record ↗
Most reported TRUWAVE, VAMP PLUS problems
Device problems
- Contamination10
- Detachment of Device or Device Component6
- Incorrect, Inadequate or Imprecise Result or Readings5
- Adverse Event Without Identified Device or Use Problem4
- Disconnection3
- Air/Gas in Device2
- Fluid/Blood Leak2
- Incorrect Measurement2
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Air Embolism2
- Altered State of Consciousness1
- Burn(s)1
- Full thickness (Third Degree) Burn1
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
- Partial thickness (Second Degree) Burn1
TRUWAVE, VAMP PLUS models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRUWAVE, VAMP PLUS PXVP2284AT3TRANSDUCER, PRESSURE, CATHETER TIP1 recall9 reports
- TRUWAVE, VAMP PLUS PXVP2284Catheter, continuous flush1 recall6 reports
- TRUWAVE, VAMP PLUS PXVP0550Catheter, continuous flush1 recall5 reports
- TRUWAVE, VAMP PLUS PXVP23X3TRANSDUCER, PRESSURE, CATHETER TIP1 recall2 reports
- TRUWAVE, VAMP PLUS PXVP2260TRANSDUCER, PRESSURE, CATHETER TIP1 recall2 reports
- TRUWAVE, VAMP PLUS PXVP23X3AT3Catheter, continuous flush1 recall2 reports
- TRUWAVE, VAMP PLUS PXVP2272TRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE, VAMP PLUS PXVP2X2AT3TRANSDUCER, PRESSURE, CATHETER TIP1 recall1 report
- TRUWAVE,VAMP PLUS PXVP0041TRANSDUCER, PRESSURE, CATHETER TIP1 recall0 reports
- TruWave, VAMP Plus PXVPL0111Catheter, Continuous Flush1 recall0 reports
- TRUWAVE, VAMP PLUS PXVP1071Catheter, continuous flush1 recall0 reports
- TRUWAVE, VAMP PLUS PXVP1087Catheter, continuous flush1 recall0 reports
- TRUWAVE, VAMP PLUS T001691MCatheter, Continuous Flush5 reports
- TruWave, VAMP Plus PXVPL2284Transducer, Pressure, Catheter Tip2 reports
- TRUWAVE, VAMP PLUS PXVP0566TRANSDUCER, PRESSURE, CATHETER TIP2 reports
- TRUWAVE/ VAMP PLUS PXVPL0030Catheter, Continuous Flush1 report
- TRUWAVE, VAMP PLUS PXVP0966TRANSDUCER, PRESSURE, CATHETER TIP1 report
Recent TRUWAVE, VAMP PLUS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Inaccurate Flow Rate
IT WAS REPORTED THAT DURING USE OF THE TRUWAVE, THE NURSE NOTICED THAT THE PRESSURE BAG FOR THE 3-WAY PRESSURE INFUSING TUBING HAD BEEN CHANGED TWO TIMES SINCE PATIENT HAD GOTTEN BACK FROM HEART SURGERY AT 13: 00. AFTER INVESTIGATING, THE NURSE FOUND THAT CVP HAD A SLOW LEAK AND PATIENT HAD BEEN RECEIVING THE FLUIDS OVER THE COURSE OF ONE AND A HALF SHIFTS. CHANGED TUBING AND THE ISSUE RESOLVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123479 ↗MalfunctionFeb 18, 2026Air/Gas in Device
AS REPORTED, AFTER ONE HOUR CONNECTED, WHEN DRAWING BLOOD, THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP, LEAKED SALINE AND APPROXIMATELY 3-5 INCHES OF AIR ENTERED IN TO THE SYSTEM FROM THE TUBING CONNECTOR TO THE TREE-WAY KEY NEXT TO THE VAMP. THE BLOOD REMAINED IN THE SYSTEM; THERE WAS NO BLOOD LEAKING. THE DEVICE WAS REPLACED WITH A NEW UNIT. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS COULD NOT BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24375268 ↗MalfunctionDec 30, 2025No Device Output; No Device Output
AS REPORTED, DURING USE IN PATIENT RECEIVING A NITROPRUSSIDE INFUSION, THIS VAMP PRESSURE SET LOST THE BLOOD PRESSURE VALUE ON THE MONITOR, THUS, PUTTING PATIENT AT RISK, AS PER CUSTOMER'S OPINION. REPLACING THE TRANSDUCER SOLVED THE ISSUE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920565 ↗MalfunctionNov 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT, DURING USE, A PRESSURE MONITORING DEVICE HAD INACCURATE PRESSURE READINGS COMPARED TO AN ARM CUFF. A-LINE READ 102/54 AND THE ARM CUFF READ 197/44. IT WAS STATED THAT THE A-LINE HAD GOOD SQUARE WAVEFORM AND ALL APPROPRIATE TROUBLESHOOTING WERE COMPLETED. NO ALLEGATIONS OF PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659314 ↗MalfunctionNov 11, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED DURING USE WITH THE PRESSURE MONITORING SET THAT THE ARTERIAL PRESSURE (SYSTOLIC, DIASTOLIC, AND MEAN) DID NOT CORRELATE WITH NIBP AND MANUAL PRESSURE. ADDITIONAL INFORMATION PROVIDED: NO ERROR MESSAGE OR ABNORMAL WAVEFORM WAS REPORTED. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525843 ↗MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE OF THE PRESSURE MONITORING SET THE BLOOD DRAWS APPEARED TO BE DILUTED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23352275 ↗MalfunctionJul 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT, DURING USE IN THE INTENSIVE CARE UNIT, THE SYSTOLIC BLOOD PRESSURE READING OF A PRESSURE MONITORING KIT WAS 40 TO 100 POINTS HIGHER THAN BOTH THE MANUAL AND AUTOMATIC CUFF PRESSURES. THOUGH THE MEAN ARTERIAL PRESSURE READINGS DID NOT CORRELATE, THE DIASTOLIC BLOOD PRESSURES WERE SIMILAR. ISSUE WAS RESOLVED BY REVIEWING THE CASE WITH A DOCTOR. NO ALLEGATIONS OF PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580981 ↗MalfunctionJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE OF THE VAMP, THE BACK END OF THE DEVICE BECAME DISCONNECTED FROM THE PLUNGER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22367529 ↗MalfunctionMay 22, 2025Disconnection; Disconnection
AS REPORTED DURING USE THE PRESSURE MONITORING KIT TUBING BECAME DISCONNECTED. THERE IS NO ADDITIONAL INFORMATION. THERE IS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22074778 ↗MalfunctionMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED DURING USE IN A PATIENT WITH THIS PRESSURE MONITORING KIT THE CONNECTION BETWEEN THE Z SITE SAMPLING SITE AND PRESSURE TUBING WAS FOUND DETACHED. THIS OCCURRED WHEN THE PATIENT POSTURE WAS BEING ADJUSTED AFTER REHABILITATION. THERE WAS ALSO BACKFLOW OF BLOOD INTO THE ARTERIAL LINE. WHEN THESE MALFUNCTIONS WERE FOUND THERE WAS NO STRONG TENSION ON THE KIT. THE CUSTOMER COMMENTED IT WAS POSSIBLE THAT SOME PRESSURE HAD BEEN APPLIED DURING REHABILITATION. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR PRODUCT EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022477 ↗MalfunctionMay 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT, WHILE POWER FLUSHING, THE PIGTAIL OF A TRUWAVE BROKE. PER THE CUSTOMER, AN ACCURATE BLOOD PRESSURE WAS UNABLE TO BE OBTAINED AND THE ALINE WAS AT RISK FOR CLOTTING. THE DEVICE WAS EXCHANGED FOR A NEW ONE. THERE WERE NO PATIENT INJURIES. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21953223 ↗MalfunctionApr 23, 2025Disconnection; Disconnection
IT WAS REPORTED BEFORE USE THAT THE ARTERIAL LINE BECAME DETACHED WITH THE PRESSURE MONITORING SET. A FAMILY MEMBER WAS SPLASHED WITH IV SOLUTION, NOT BLOOD. THERE WAS NO HARM OR INJURY TO THE FAMILY MEMBER. THE EDWARDS REPRESENTATIVE PROVIDED ON-SITE EDUCATION. THERE WAS NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21894142 ↗MalfunctionApr 23, 2025Disconnection; Disconnection
IT WAS REPORTED THAT BEFORE USE WITH A PRESSURE MONITORING SET THAT THERE WAS A TUBE THAT BECAME DETACHED. THE FACILITY IS UNABLE TO INDICATE THE LOCATION OF THE TUBING THAT BECAME DETACHED. THE USER HAD TIGHTENED ALL THE CONNECTIONS. THERE IS NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21894120 ↗InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, A PATIENT RECEIVED A MAGNETIC RESONANCE IMAGING (MRI) THERMAL BURN WHILE CONNECTED TO THIS PRESSURE MONITORING SYSTEM. THE TRANSDUCER WAS LOCATED AT THE PATIENT'S HUMERUS AND CONNECTED TO AN IRADIMED ARTERIAL LINE MONITORING POD. THE PATIENT REQUIRED WOUND CONSULTS AND MEDICATED CREAM FOR THE THERMAL INJURY ON THE RIGHT HUMERUS. NO SURGICAL INTERVENTION WAS REQUIRED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PRODUCT NON-CONFORMANCE WITH THE PRESSURE MONITORING KIT AND THEY WILL PROVIDE EDUCATION TO THEIR HOSPITAL STAFF REGARDING MRI SAFETY.
Patient problems: Burn(s)
MAUDE report 21715515 ↗InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED 7 MARCH 2025: PER CUSTOMER, THE STRENGTH OF THE MRI WAS 1.5 TESLA, THE PATIENT WAS UNDERGOING A LENGTHY MRI FOR CERVICAL, THORACIC, AND LUMBAR SPINES. THE SCAN TIME WAS 1 HOUR 46 MINUTES ON/OFF FOR CARE AS NEEDED. THE PATIENT WAS LAYING FACE UP IN SPINAL PRECAUTIONS. THE PATIENT WAS A TRAUMATIC QUADRIPLEGIA, AND HE WAS INTUBATED AND SEDATED. THE PATIENT REQUIRED LEFT SHOULDER EXCISIONAL DEBRIDEMENT AND APPLICATION OF ARTIFICIAL SKIN GRAFT. PRODUCT QUALITY CLINICIAN SPOKE DIRECTLY WITH CUSTOMER TO INFORM THEM THAT THIS DEVICE IS NOT TO BE USED IN THE BORE OF THE MRI. THE CUSTOMER STATED THAT SHE WILL PROVIDE EDUCATION TO HOSPITAL STAFF.
Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn
MAUDE report 21447086 ↗
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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