VolumeView VLV8R520Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103187014), received between Sep 9, 2024 and Jan 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN A PATIENT IN THE NEUROLOGICAL ICU (INTENSIVE CARE UNIT), WHEN HANDLING THE MANIFOLD OF THIS VOLUMEVIEW SENSOR, IT BROKE INTO TWO PIECES. THE DEVICE WAS REPLACED BY A NEW ONE. THE BLOOD LOSS WAS MINIMAL. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21112232 ↗
• MalfunctionJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN A PATIENT IN THE CARDIAC ICU (INTENSIVE CARE UNIT), WHEN HANDLING THE MANIFOLD OF THIS VOLUME VIEW SENSOR, IT BROKE INTO TWO PIECES (COMPLAINT (B)(4) / MFR 2015691-2025-00170). THE DEVICE WAS REPLACED BY A NEW ONE AND, AFTER TWO DAYS OF USE, THE MANIFOLD ALSO BROKE INTO TWO PIECES (COMPLAINT (B)(4). A THIRD DEVICE WAS USED. THE BLOOD LOSS WAS MINIMAL. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION SINCE THEY WERE DISCARDED; HOWEVER, AN IMAGE OF THE DEVICE INVOLVED IN THE COMPLAINT (B)(4) WAS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21111941 ↗
• MalfunctionJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN A PATIENT IN THE CARDIAC ICU (INTENSIVE CARE UNIT), WHEN HANDLING THE MANIFOLD OF THIS VOLUMEVIEW SENSOR, IT BROKE INTO TWO PIECES (COMPLAINT (B)(4)). THE DEVICE WAS REPLACED BY A NEW ONE AND, AFTER TWO DAYS OF USE, THE MANIFOLD ALSO BROKE INTO TWO PIECES (COMPLAINT (B)(4)). A THIRD DEVICE WAS USED. THE BLOOD LOSS WAS MINIMAL. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION SINCE THEY WERE DISCARDED; HOWEVER, AN IMAGE OF THE DEVICE INVOLVED IN THE COMPLAINT (B)(4) WAS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21111872 ↗
• MalfunctionSep 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING USE IN PATIENT OF THIS VOLUME VIEW SENSOR, AN UNKNOWN QUANTITY OF MEDICATION (METHYLENE BLUE) LEAKED FROM THE MANIFOLD. NO ACTION REQUIRED DUE TO MEDICATION LOSS. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167344 ↗