NON-DEHP, SINGLE DPT LINE WITH VAMP JR RESERVOIR AND LASS PXVJ050MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07460691960572), received between Jun 17, 2024 and Feb 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

11 other recalls cover devices cleared under the same FDA submission (K142749); 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 6, 2026Leak/Splash

  AS REPORTED, WHEN RETURNING BLOOD FROM PREVIOUSLY EXTRACTED BLOOD SAMPLE TO AN ICU PATIENT, THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) WITH VAMP JUNIOR EXPERIENCED RESISTANCE, AS CONSEQUENCE, BLOOD SPRAYED FROM SAMPLE PORT TO STAFF MEMBER FACE AND TRUNK. THE DISTAL STOPCOCK WAS OPEN DURING PROCESS. A NEW TRANSDUCER WAS USED FROM THE SAME LOT, HOWEVER, IT ALSO EXPERIENCED RESISTANCE PUSHING THE PLUNGER RESULTING IN SALINE SPRAYING FROM SAMPLE PORT. THE NURSE WORE GLOVES BUT NO GOGGLES NOR FACEMASK. SEROLOGY TESTS WERE PERFORMED TO THE PATIENT AND NURSE AND CAME BACK NEGATIVE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: Fluid Discharge

  MAUDE report 24278251 ↗
• MalfunctionJun 17, 2024Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  AS REPORTED, DURING USE IN PATIENT WITH THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP JR, THE PRESSURE TUBING BECAME DISCONNECTED RIGHT BESIDE THE SAMPLING SYRINGE. WHILST TAKING A SAMPLE OF BLOOD FROM THE PATIENT THE NURSE NOTICED A SMALL PATCH OF BLOOD ON THE SHEETS WHICH SHE FOUND TO BE AS A RESULT OF THE BONDED TUBE CONNECTION BREAKING OFF. THE LINE WAS IMMEDIATELY CLAMPED, AND THE ARTERIAL LINE PRESSURE TRANSDUCER KIT WAS CHANGED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19547053 ↗

Recalls under the same FDA submission

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

• Z-0413-2024 · Oct 4, 2023 · Open, Classified
  TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc),
• 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-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-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-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-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-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-1962-2021 · May 26, 2021 · Terminated
  Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
• 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-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