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CARDINAL HEALTH SAN13AN60DRecalls & reported problems

Cardinal Health 200, LLC · ANGIOGRAPHY PACK · Class 2

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439684230), received between Oct 7, 2020 and Oct 8, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

  • Device Contamination with Chemical or Other Material1
  • Material Fragmentation1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 8, 2020Device Contamination with Chemical or Other Material

    BASED ON INFORMATION FROM THE CUSTOMER THE BLUE TOWEL IS LAID ON THE DRAPE TO ABSORB FLUIDS, REPORTEDLY IF YOU TOUCH IT, SMALL PIECES COME OFF ON YOUR HANDS OR EQUIPMENT.

    Patient problems: Insufficient Information

    MAUDE report 10648570 ↗
  • MalfunctionOct 7, 2020Material Fragmentation

    BASED ON INFORMATION FROM THE CUSTOMER THE BLUE TOWEL IS LAID ON THE DRAPE TO ABSORB FLUIDS, REPORTEDLY IF YOU TOUCH IT, SMALL PIECES COME OFF ON YOUR HANDS OR EQUIPMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10642341 ↗

Other Angiography/angioplasty kit devices

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Sources and updates

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