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CARDINAL HEALTH SCV23IRCHARecalls & reported problems

Cardinal Health 200, LLC · STERILE IR AORTAGRAM PACK · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488708577), received between Mar 11, 2019 and Mar 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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.

Most reported problems

Device problems

  • Contamination /Decontamination Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 11, 2019Contamination /Decontamination Problem

    THE CUSTOMER REPORTED THAT THE BLUE OPERATING ROOM TOWELS PWTB03-STMA FROM THE INTERVENTIONAL RADIOLOGY AORTAGRAM PACK/SCV23IRCHA WERE LINTING AND THEIR GLOVES RETAINED THE LINT. THE TOWELS WERE USED TO SOAK UP BLOOD AND NORMAL SALINE. THERE WAS NO INJURY. NEW GLOVES AND NORMAL SALINE WERE OBTAINED AND USED TO COMPLETE THE PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8410077 ↗

Other Angiography/angioplasty kit devices

All Angiography/angioplasty kit devices →

Sources and updates

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