Medline Industries, Inc. DYNJ50615CRecalls & reported problems
Medline Industries, Inc. · ANGIO PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327323189), received between Mar 25, 2024 and Apr 3, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (3 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
- Material Integrity Problem3
- Detachment of Device or Device Component1
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.
MalfunctionApr 3, 2024Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY ON 05/31/2023 WHILE THE DOCTOR WAS INJECTING CONTRAST THE SYRINGE BROKE WHILE IN THE USER'S HAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19032976 ↗MalfunctionMar 26, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
IT WAS REPORTED THAT THE SYRINGE COMPONENTS IN THE PACK "SEEM TO EXPLODE OR COME APART DURING PROCEDURES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18977556 ↗MalfunctionMar 25, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A SYRINGE COMPONENT IS "EXPLODING" AND "COMING APART" WHEN ADMINISTERING CONTRAST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18976247 ↗
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- 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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