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Medline Industries, Inc. DYNJ45323FRecalls & reported problems

Medline Industries, Inc. · CARDIAC CATH TRAY · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10195327082369), received between Jun 21, 2024 and Sep 23, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 3 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available2
  • Connection Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionSep 23, 2024Connection Problem; Connection Problem

    SYRINGE FELL OFF MANIFOLD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20280436 ↗
  • MalfunctionSep 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE FACILITY THE CONTROL SYRINGE DOES NOT STAY TIGHT AND FALLS OFF ON ITS OWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20279554 ↗
  • MalfunctionSep 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE FACILITY THE CONTROL SYRINGE DOES NOT STAY TIGHT AND FALLS OFF ON ITS OWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20250576 ↗
  • MalfunctionJun 21, 2024Connection Problem; Connection Problem

    CONTROL SYRINGE NOT LOCKING TO MANIFOLD.

    Patient problems: Insufficient Information

    MAUDE report 19585992 ↗

Other Cardiac catheterization kit devices

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Sources and updates

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