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Medline Industries, Inc. DYNJV0155XRecalls & reported problems

Medline Industries, Inc. · CARDIAC PACK · 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 10198459225239), received between Oct 12, 2025 and Sep 24, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 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: 1 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: 3 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Deformation Due to Compressive Stress2
  • Detachment of Device or Device Component1
  • Loose or Intermittent Connection1

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 24, 2026Deformation Due to Compressive Stress

    It was reported that "Manifold rotating adaptor blows off during injections," "Contrast tubing has kinks/damaged tubing," "Another damaged contrast line," "Manifold leaking air," "2 Manifolds with severely damaged contrast tubing," and "More damaged contrast tubing."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50884995 ↗
  • MalfunctionSep 21, 2026Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50841228 ↗
  • MalfunctionSep 12, 2026Deformation Due to Compressive Stress

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50746792 ↗
  • MalfunctionOct 12, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT THE ROTATING ADAPTOR FROM THE CONTROL SYRINGE IS BACKING OFF OF THE MANIFOLD BODY.

    Patient problems: Insufficient Information

    MAUDE report 23275613 ↗

Other Cardiovascular procedure kit devices

All Cardiovascular procedure kit devices →

Sources and updates

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