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
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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