Medline Industries, Inc. DYNJV0282KRecalls & reported problems
Medline Industries, Inc. · ANGIOGRAPHY DRAPE PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327538965), received between Jul 16, 2025 and Jul 22, 2025 — classified as 3 injuries.
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
Most reported problems
Device problems
- Connection Problem2
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Air/Gas in Device; Air/Gas in Device
ACCORDING TO THE FACILITY "AIR (IS) BEING INTRODUCED INTO THEIR MANIFOLD".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566909 ↗InjuryJul 21, 2025Connection Problem; Connection Problem
ACCORDING TO THE FACILITY "AIR (IS) BEING INTRODUCED INTO THEIR MANIFOLD". PER THE FACILITY "AT THE CONNECTION POINT ON THE PRESSURE TUBING, THE LUER LOCK IS CAUSING EXCESSIVE AIR (TO BE) INTRODUCED INTO THE SYSTEM".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22562175 ↗InjuryJul 16, 2025Connection Problem; Connection Problem
ACCORDING TO THE FACILITY "AIR (IS) BEING INTRODUCED INTO THEIR MANIFOLD". PER THE FACILITY "AT THE CONNECTION POINT ON THE PRESSURE TUBING, THE LUER LOCK IS CAUSING EXCESSIVE AIR (TO BE) INTRODUCED INTO THE SYSTEM".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22524797 ↗
Other Cardiac catheterization kit devices
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- Medline Industries, Inc. MNS9935Medline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC5540ACenturion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC2745Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC6505Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
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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