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CARDINAL HEALTH SANCGCAACARecalls & reported problems

Cardinal Health 200, LLC · CORONARY ANGIO DRAPE CMC · Class 2

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

Adverse event reports
10
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10888439647228), received between Sep 11, 2020 and Sep 11, 2020 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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.

Most reported problems

Device problems

  • Material Fragmentation6
  • Device Contamination with Chemical or Other Material3
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Insufficient Information4
  • No Patient Involvement1

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 11, 2020Material Fragmentation

    CUSTOMER REPORTED LINTING FROM OR TOWEL. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10523385 ↗
  • MalfunctionSep 11, 2020Material Fragmentation

    CUSTOMER REPORTED LINTING FROM OR TOWEL. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10523380 ↗
  • MalfunctionSep 11, 2020Device Contamination with Chemical or Other Material

    CUSTOMER REPORTED LINTING FROM OR TOWEL. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 10523317 ↗
  • MalfunctionSep 11, 2020Material Fragmentation

    CUSTOMER REPORTED LINTING FROM OR TOWEL. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10523275 ↗
  • MalfunctionSep 11, 2020Appropriate Device Problem Term/Code Not Available

    CUSTOMER REPORTED LINTING FROM OR TOWEL. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 10523233 ↗
  • MalfunctionSep 11, 2020Device Contamination with Chemical or Other Material

    CUSTOMER REPORTED LINTING FROM OR TOWEL. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 10523212 ↗
  • MalfunctionSep 11, 2020Material Fragmentation

    CUSTOMER REPORTED LINTING FROM OR TOWEL. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10523100 ↗
  • MalfunctionSep 11, 2020Device Contamination with Chemical or Other Material

    CUSTOMER REPORTED LINTING FROM OR TOWEL. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 10522798 ↗
  • MalfunctionSep 11, 2020Material Fragmentation

    LINTING FROM OR TOWELS. NOTE: PHOTO OF THE PRODUCT, LOT # CANNOT BE PROVIDED BY THE SALES REP.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10522748 ↗
  • MalfunctionSep 11, 2020Material Fragmentation

    CUSTOMER REPORTED LINTING FROM OR TOWEL. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 10522502 ↗

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Sources and updates

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