TRUWAVE, VAMP PLUS T001691MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07460691959477), received between May 7, 2024 and Dec 30, 2025 — classified as 5 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K181684); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 6, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT, THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP PLUS PROVIDED ARTERIAL BLOOD PRESSURE VALUES (200/90) SIGNIFICANTLY DIFFERENT THAN THE ONES PROVIDED BY A NON-INVASIVE DEVICE (160/80). MEASUREMENTS WERE MADE BY BOTH DEVICES IN THE SAME ARM. THE VALUES EXPECTED ACCORDING TO PATIENT STATUS WERE AROUND 140-160/80. NO ERROR MESSAGE NOR ALARM WAS DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO WRONG VALUES PROVIDED. THE DEVICE WAS REPLACED BY A NEW ONE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322119 ↗
• MalfunctionJul 2, 2024Mechanical Jam; Mechanical Jam

  AS REPORTED, DURING USE IN PATIENT WITH THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP PLUS, WHEN THE USER WENT TO TAKE A SAMPLE FOR LABORATORY TESTS, THE DISTAL SAMPLING SITE WAS FOUND COMPLETELY COLLAPSED AND IT WAS NOT POSSIBLE TO BE RETURNED TO ITS INITIAL POSITION. THE BLOOD WAS LEAKING CONTINUOUSLY. THE DEVICE WAS CHANGED FOR A NEW ONE AND NO ADDITIONAL INTERVENTION WAS NEEDED TO SOLVE THE ISSUE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19655921 ↗
• MalfunctionMay 17, 2024Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  AS REPORTED, DURING USE IN PATIENT WITH THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP SYSTEMS, THERE WAS A SALINE LEAKAGE AT THE LEVEL OF THE SHUT-OFF VALVE. IN ADDITION, THERE WAS A BLOOD BACKFLOW DUE TO LOSS OF AIRTIGHTNESS OF THE SYSTEM THAT MUST BE CLOSE. THEREFORE THE SYSTEM MUST BE CHANGED BECAUSE IT PRESENTED FILTRATION AND ENTERED AIR INTO THE SYSTEM WITH RISK OF COAGULATION AND DYSFUNCTION. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339341 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT WITH THIS TRUWAVE VAMP PLUS, THE PRESSURE TUBING DETACHED AND THE SOLUTION LEAKED. THERE WAS NO PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257676 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181684. 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)