Medline Industries, Inc. VASC1131Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10889942854325), received between Nov 11, 2020 and Nov 11, 2020 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathNov 11, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE TRANSDUCER SEAL FAILED AND DREW AIR IN DURING A PROCEDURE REQUIRING REPLACEMENT OF THE DEVICE AND DELAYING PATIENT CARE.

  Patient problems: Death; Therapeutic Response, Decreased

  MAUDE report 10825226 ↗
• MalfunctionNov 11, 2020Break; Leak/Splash

  IT WAS REPORTED THAT THE MIDDLE CONNECTOR OF THE MANIFOLD BROKE DURING A PROCEDURE CAUSING THE MANIFOLD TO LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10824334 ↗
• MalfunctionNov 11, 2020Leak/Splash; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE TRANSDUCER ON THE MANIFOLD WAS NOT SEALED PROPERLY ALLOWING BLOOD AND AIR TO LEAK DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10824221 ↗
• MalfunctionNov 11, 2020Crack; Improper Flow or Infusion

  IT WAS REPORTED THAT THERE WERE CRACKED TRANSDUCER CONNECTIONS WHICH LED TO BLOOD FLOWING BACK INTO THE MANIFOLD THROUGHOUT THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10824071 ↗
• MalfunctionNov 11, 2020Leak/Splash

  IT WAS REPORTED THAT THE TRANSDUCER SEAL WAS NOT TIGHT AND LEAKED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10823881 ↗
• MalfunctionNov 11, 2020Loose or Intermittent Connection; Separation Problem

  IT WAS REPORTED THAT THE CONTROL SYRINGE MALFUNCTIONED. REPORTEDLY THE SYRINGE DID NOT TIGHTEN AND KEPT COMING OFF OF ITS ATTACHMENT DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10823600 ↗
• MalfunctionNov 11, 2020Break; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE TRANSDUCER ON THE DEVICE WAS BROKEN. THE CLINICIAN WAS UNABLE TO CONNECT THE DEVICE WITH THE MANIFOLD DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10823336 ↗