Medline Industries, Inc. DYNJ04508ORecalls & reported problems
Medline Industries, Inc. · ANGIOGRAPHY PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10195327475543), received between Apr 4, 2024 and Apr 4, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (5 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 Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2024Connection Problem; Connection Problem
ACCORDING TO THE CUSTOMER, "BD SYRINGE WITH THIS SUBCOMPONENT IS UNACCEPTABLE. AIR LEAKS THROUGH, SO THE CUSTOMER HAS BEEN HAVING TO TOSS IT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19042748 ↗MalfunctionApr 4, 2024Connection Problem; Connection Problem
ACCORDING TO THE CUSTOMER, "BD SYRINGE WITH THIS SUBCOMPONENT IS UNACCEPTABLE. AIR LEAKS THROUGH, SO THE CUSTOMER HAS BEEN HAVING TO TOSS IT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19042393 ↗MalfunctionApr 4, 2024Connection Problem; Connection Problem
ACCORDING TO THE CUSTOMER, "BD SYRINGE WITH THIS SUBCOMPONENT IS UNACCEPTABLE. AIR LEAKS THROUGH, SO THE CUSTOMER HAS BEEN HAVING TO TOSS IT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19042163 ↗MalfunctionApr 4, 2024Connection Problem; Connection Problem
ACCORDING TO THE CUSTOMER, "BD SYRINGE WITH THIS SUBCOMPONENT IS UNACCEPTABLE. AIR LEAKS THROUGH, SO THE CUSTOMER HAS BEEN HAVING TO TOSS IT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19041950 ↗MalfunctionApr 4, 2024Connection Problem; Connection Problem
ACCORDING TO THE CUSTOMER, "BD SYRINGE WITH THIS SUBCOMPONENT IS UNACCEPTABLE. AIR LEAKS THROUGH, SO THE CUSTOMER HAS BEEN HAVING TO TOSS IT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19041680 ↗
Other Cardiac catheterization kit devices
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- Medline Industries, Inc. DYNJ0578916XMedline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- 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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