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CARDINAL HEALTH SCVHFOHSH5Recalls & reported problems

Cardinal Health 200, LLC · CPT, OPEN HEART 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 10888439661880), received between Feb 25, 2020 and Feb 25, 2020 — 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.

  • MalfunctionFeb 25, 2020Contamination /Decontamination Problem

    BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THEY HAVE REPORTEDLY BEEN NOTICING ISSUES WITH LINT COMING OFF THE BLUE TOWELS THAT COME IN THE OPEN HEART PACK. PER THE CUSTOMER, THERE HAVE BEEN NO PATIENTS AFFECTED OR HURT DUE TO THIS ISSUE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9751758 ↗

Other Cardiovascular procedure kit devices

All Cardiovascular procedure kit devices →

Sources and updates

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