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Medline DYNJP4001Recalls & reported problems

Medline Industries, Inc. · DRAPE,CV,UNFENESTRATED,STERILE · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10080196740680), received between Nov 26, 2018 and Nov 26, 2018 — classified as 1 injury.

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 16, 2026.

Most reported problems

Device problems

  • Contamination /Decontamination Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • InjuryNov 26, 2018Contamination /Decontamination Problem

    IT WAS REPORTED THAT DURING A MITRAL VALVE REPAIR, THE DRAPE SHED FOAM INTO THE SURGICAL SITE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8102509 ↗

Other Drape, surgical devices

All Drape, surgical devices →

Sources and updates

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