Merit Medical® 00884450391235Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450391235), received between Jul 27, 2022 and Jul 27, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 11, 2024Class IIOpen, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2579-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗

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.

• MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A THORACENTESIS, THE PHYSICIAN NOTICED A LEAKY VALVE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114741 ↗
• MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A THORACENTESIS, THE PHYSICIAN NOTICED A LEAKY VALVE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114737 ↗
• MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A THORACENTESIS, THE PHYSICIAN NOTICED A LEAKY VALVE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114695 ↗
• MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A THORACENTESIS, THE PHYSICIAN NOTICED A LEAKY VALVE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114693 ↗
• MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING A THORACENTESIS, THE PHYSICIAN NOTICED A LEAKY VALVE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114678 ↗