TRUWAVE PX284ANRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07460691950245), received between May 1, 2023 and Jan 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

11 other recalls cover devices cleared under the same FDA submission (K142749, K171996); 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.

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.

• MalfunctionJan 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE THREADS ON SYRINGES & THREADS ON TRANSDUCER ARE NOT LINING UP, CAUSING SYRINGE TIP TO BREAK OFF IN THE TRANSDUCER. WHEN COMING ON SHIFT, THE CUSTOMER NOTED THAT THE SYRINGE HOOKED UP TO STOPCOCK ON THE CVP TRANSDUCER WAS LEAKING EVEN THOUGH IT APPEARED CONNECTED. WHEN INSPECTING FURTHER, THE CUSTOMER NOTED THE TIP BROKE OFF INTO THE STOP COCK. THIS MEANT THE TRANSDUCER WASN'T ZEROED TO AIR DURING THE PREVIOUS SHIFT. WHEN NEW TRANSDUCER AND SYRINGE WERE HOOKED UP (SYRINGE FROM DIFFERENT LOT BUT TRANSDUCER FROM SAME LOT), IT IMMEDIATELY BROKE OFF AGAIN BEFORE SYRINGE WAS EVEN TWISTED ON ALL THE WAY. NEW TRANSDUCER GRABBED FROM NEW LOT AND SYRINGE SCREWED ON WITHOUT ANY ISSUES. CHARGE NOTIFIED OF EQUIPMENT ISSUE. NO ALLEGATION OF PATIENT INJURY, DEVICE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21104901 ↗
• MalfunctionMay 1, 2023Crack; Fluid/Blood Leak

  EARLY 60¿S MALE WITH HISTORY OF CORONARY ARTERY DISEASE AND RECENT SHORTNESS OF BREATH. 7 DAYS POST OP FROM CORONARY ARTERY BYPASS GRAFT X 1 AND MONITORED IN CVICU. A NEW PACKAGE OF TRUWAVE 3CC PRESSURE TUBING OPENED TO CHANGE ARTERIAL LINE. WHEN THE TUBING WAS PRIMED, TUBING WAS WET AND THERE WAS A PUDDLE ON THE FLOOR. A CRACK WAS VISUALIZED IN THE TUBING AND THE TUBING WAS REMOVED, WITHOUT KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR TRANSDUCER, PRESSURE, CATHETER TIP, TRUWAVE (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843322 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142749, K171996. 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-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-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-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-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-1966-2021 · May 26, 2021 · Terminated
  Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
• 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