Medline Industries, Inc. DYNJ17218URecalls & reported problems
Medline Industries, Inc. · ANGIOGRAPHY PACK II · 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 10198459162947), received between Apr 3, 2025 and Apr 3, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Crack3
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, 2025Crack; Crack
ACCORDING TO THE FACILITY, ON 3/6 AT THE BEGINNING OF A LOWER EXTREMITY ARTERIOGRAM, "HE WAS INJECTING INTO A SHEATH OR CATHETER FOR FIRST IMAGING AFTER CONFIRMING FLUID TO FLUID CONNECTION. WHEN HE INJECTED, IT SPRAYED ALL OVER THE ROOM". THIS OCCURRED 3 TIMES AND THE SYRINGES WERE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767860 ↗MalfunctionApr 3, 2025Crack; Crack
ACCORDING TO THE FACILITY, ON (B)(6) AT THE BEGINNING OF A LOWER EXTREMITY ARTERIOGRAM, "HE WAS INJECTING INTO A SHEATH OR CATHETER FOR FIRST IMAGING AFTER CONFIRMING FLUID TO FLUID CONNECTION. WHEN HE INJECTED, IT SPRAYED ALL OVER THE ROOM". THIS OCCURRED 3 TIMES AND THE SYRINGES WERE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767378 ↗MalfunctionApr 3, 2025Crack; Crack
ACCORDING TO THE FACILITY, ON (B)(6) AT THE BEGINNING OF A LOWER EXTREMITY ARTERIOGRAM, "HE WAS INJECTING INTO A SHEATH OR CATHETER FOR FIRST IMAGING AFTER CONFIRMING FLUID TO FLUID CONNECTION. WHEN HE INJECTED, IT SPRAYED ALL OVER THE ROOM". THIS OCCURRED 3 TIMES AND THE SYRINGES WERE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767095 ↗
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- Medline Industries, Inc. ECVC2555Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
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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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