TRUWAVE PX260Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07460691950191), received between Apr 22, 2024 and Mar 31, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Contamination” (10 reports).

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

10 other recalls cover devices cleared under the same FDA submission (K142749, K171996, K183413); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 7, 2026Contamination

  AS REPORTED, WHEN SETTING UP THIS DISPOSABLE TRANSDUCER, A PART WAS LOOSE. NO FURTHER INFORMATION AVAILABLE. THERE IS NO ALLEGATION OF PATIENT INJURY. AS PER PRODUCT EVALUATION FINDINGS, FILTER WAS FOUND DISLODGED INSIDE DRIP CHAMBER DURING VISUAL EXAMINATION. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988585 ↗
• MalfunctionJan 7, 2026Incorrect Measurement

  AS REPORTED, USE IN A PATIENT WITH AN AORTIC VALVE CONDITION, THIS PRESSURE MONITORING SET SHOWED A MEAN ARTERIAL PRESSURE (MAP) OF 33 MMHG, WHEN THE EXPECTED MAP BASED ON THE PATIENT'S CONDITION WAS 60-65 MMHG. NO ERROR MESSAGE WAS DISPLAYED. THE ISSUE WAS SOLVED REPLACING THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988338 ↗
• MalfunctionJan 7, 2026Contamination

  AS REPORTED, THIS PRESSURE MONITORING SET HAD THE CONNECTOR BROKEN. THERE IS NO ALLEGATION OF PATIENT INJURY. AS PER PRODUCT EVALUATION FINDINGS, FILTER WAS FOUND DISLODGED INSIDE DRIP CHAMBER DURING VISUAL EXAMINATION. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988187 ↗
• MalfunctionDec 16, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT THIS PRESSURE MONITORING SET DISPLAYED INACCURATE VALUES. THE DATA DISPLAYED DIFFERED GREATLY FROM THE EXPECTED VALUES ACCORDING TO THE PATIENT'S CONDITIONS. THERE WAS NO COMPARATIVE DATA OBTAINED FROM ANOTHER SOURCE. REPLACING THE SENSOR WITH A NEW ONE SOLVED THE ISSUE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RECEIVED FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820701 ↗
• MalfunctionDec 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, BEFORE USING THIS PRESSURE MONITORING SET, IT WAS FOUND THAT THE POUCH WAS NOT SEALED AND DID NOT MEET STERILE STANDARDS, THEREFORE, IT WAS REPLACED. NO PICTURE IS AVAILABLE. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787844 ↗
• MalfunctionOct 24, 2025Contamination; Contamination

  AS REPORTED, BEFORE USE IN PATIENT WITH THIS DISPOSABLE PRESSURE TRANSDUCER (DPT), SOME SUBSTANCE WAS OBSERVED IN THE TUBE. ADDITIONALLY, THE DPT COULD NOT BE ZEROED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379309 ↗
• MalfunctionApr 10, 2025Break

  AT LEAST 3 SEPARATE INCIDENTS HAVE OCCURRED INVOLVING ARTERIAL LINE PRESSURE MONITORING TUBING. SPECIFICALLY, THE BLUE RUBBER "PIG TAIL" HAS BROKEN OFF WHEN FLUSHING AND OR ZEROING A PATIENT'S ARTERIAL LINE. NO EXCESSIVE FORCE WAS USED IN ANY OF THESE OCCURRENCES WHERE PIG TAIL HAS BROKEN OFF. MANUFACTURER RESPONSE FOR TRANSDUCER, PRESSURE, CATHETER TIP, TRUWAVE (PER SITE REPORTER).

  Patient problems: Insufficient Information

  MAUDE report 21813481 ↗
• MalfunctionFeb 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, THE PRESSURE TUBING CONNECTOR OF THIS PRESSURE MONITORING SET WAS DISCONNECTED FROM THE DPT HOUSING BECAUSE IT WAS POORLY SCREWED. THEREFORE, THERE WAS BACKFLOW OF BLOOD IN THE LINE. THE PRESSURE TUBING WAS CLAMPED AND CHANGED. THERE WAS NO ALLEGATION OF PATIENT INJURY BUT DELAY IN THE PROCEDURE. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468383 ↗
• MalfunctionFeb 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, THE PRESSURE TUBING CONNECTOR OF THIS PRESSURE MONITORING SET WAS DISCONNECTED FROM THE DPT HOUSING BECAUSE IT WAS POORLY SCREWED. THEREFORE, THERE WAS BACKFLOW OF BLOOD IN THE LINE. THE PRESSURE TUBING WAS CLAMPED AND CHANGED. THERE WAS NO ALLEGATION OF PATIENT INJURY BUT DELAY IN THE PROCEDURE. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468315 ↗
• MalfunctionNov 29, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, THIS DISPOSABLE PRESSURE TRANSDUCER WAS NOT READING CORRECTLY. NO MORE INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY REPORTED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHIC DATA UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809300 ↗
• MalfunctionNov 15, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN A SURGICAL PROCEDURE, THIS DISPOSABLE PRESSURE TRANSDUCER CONNECTED TO AN ARTERIAL LINE PROVIDED INACCURATE PRESSURE VALUES (E.G. 93/28, 80/16, 68/15 MMHG). THERE WAS NO ERROR MESSAGE DISPLAYED. THE VALUES WERE FIRSTLY CONFIRMED TO BE INCORRECT BY COMPARING WITH THE ONES PROVIDED BY NON-INVASIVE BLOOD PRESSURE MEASUREMENTS (E.G. 126/88, 112/73, 101/57 MMHG). THERE WAS ANOTHER DPT WORKING CORRECTLY CONNECTED TO A CENTRAL LINE TO MEASURE CENTRAL VENOUS PRESSURE (CVP). THE DPT THAT MALFUNCTIONED WAS CONNECTED TO THIS ACCESS AND IT WAS RE-CONFIRMED THAT IT DID NOT WORK CORRECTLY SINCE IT PROVIDED NEGATIVE CVP VALUES, 4 TO 5 TIMES LOWER THAN THE CORRECT ONES. THEN, A NEW DPT WAS CONNECTED TO THE ARTERIAL LINE AND THE ISSUE WAS SOLVED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES. THE DEVICE MALFUNCTION DID NOT CAUSE PATIENT INJURY NOR AFFECTED THE SURGICAL PROCEDURE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693312 ↗
• MalfunctionAug 23, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, AFTER FLUSHING AND ZEROING THIS DISPOSABLE PRESSURE TRANSDUCER CONNECTED TO PATIENT, BLOOD PRESSURE PARAMETER WAS MUCH LOWER THAN MEASUREMENT OBTAINED BY A NON-INVASIVE PRESSURE MONITORING. THE DEVICE WAS REMOVED AND RECONNECTED AGAIN BUT THE ISSUE REMAINED. THE DEVICE WAS REPLACED WITH A NEW UNIT AND ISSUE WAS SOLVED. THE PATIENT WAS NOT TREATED ACCORDING TO THE WRONG PARAMETER. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050191 ↗
• MalfunctionAug 14, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, DURING RECEIVING INSPECTION AT CHINA UPS WAREHOUSE, THIS DISPOSABLE PRESSURE TRANSDUCER HAD BIOLOGICAL MATERIALS IN STERILIZATION PACKAGING. THERE WAS NO PATIENT INVOLVED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19979915 ↗
• MalfunctionJul 23, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, DURING CHECKING THIS DISPOSABLE PRESSURE TRANSDUCER, THE STERILE PACKAGING WAS FOUND DAMAGED. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19803919 ↗
• MalfunctionJul 10, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT, THIS DISPOSABLE PRESSURE TRANSDUCER PROVIDED UNSTABLE PRESSURE VALUES. THE ISSUE WAS SOLVED REPLACING WITH A NEW UNIT. THERE WAS NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710692 ↗
• MalfunctionJun 28, 2024Contamination; Contamination

  AS REPORTED, DURING SET-UP, THIS DISPOSABLE PRESSURE TRANSDUCER SNAP-TAB HAD SALINE LEAKAGE. THE DEVICE WAS REPLACED BY A NEW UNIT. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE OBTAINED. THE DEVICE WAS RECEIVED FOR EVALUATION AND THREE UNKNOWN BLACK PARTICLES WERE FOUND INSIDE THE IV TUBING. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631135 ↗
• MalfunctionJun 19, 2024Contamination; Contamination

  INITIALLY, IT WAS REPORTED THAT DURING SET-UP THIS DISPOSABLE PRESSURE TRANSDUCER, THE SNAP-TAB HAD SALINE LEAKAGE. THE DEVICE WAS REPLACED BY A NEW UNIT. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE OBTAINED. THE DEVICE WAS RECEIVED FOR EVALUATION AND UNKNOWN BLACK PARTICLES WERE FOUND INSIDE THE IV TUBING. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566600 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142749, K171996, K183413. One submission often covers many models, so check the product and lot details in each record.

• Z-0414-2024 · Oct 4, 2023 · Open, Classified
  TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm)
• Z-1966-2021 · May 26, 2021 · Terminated
  Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
• Z-1963-2021 · May 26, 2021 · Terminated
  Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
• Z-1965-2021 · May 26, 2021 · Terminated
  Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
• Z-1964-2021 · May 26, 2021 · Terminated
  Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
• Z-1959-2021 · May 26, 2021 · Terminated
  Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
• Z-1961-2021 · May 26, 2021 · Terminated
  Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***N
• Z-1960-2021 · May 26, 2021 · Terminated
  Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
• Z-1962-2021 · May 26, 2021 · Terminated
  Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
• Z-2776-2015 · Jul 31, 2015 · Terminated
  Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For