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Medline Industries, Inc. CDS983965DRecalls & reported problems

Medline Industries, Inc. · OPEN HEART CDS · Class 2

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889942885961), received between Apr 22, 2019 and May 3, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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

  • Break2
  • Detachment of Device or Device Component2

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 3, 2019Break

    IT WAS REPORTED THAT THE TIP OF THE MEDTRONIC SET CATH PLACEMENT PRESSURE LINE BROKE OFF INTO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8579703 ↗
  • MalfunctionApr 22, 2019Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE TIP OF THE MEDTRONIC SET CATH PLACEMENT PRESSURE LINE BROKE OFF INTO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8536530 ↗
  • MalfunctionApr 22, 2019Detachment of Device or Device Component

    IT WAS REPORTED THAT THE TIP OF THE MEDTRONIC SET CATH PLACEMENT PRESSURE LINE BROKE OFF INTO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8536458 ↗

Other Cardiovascular procedure kit devices

All Cardiovascular procedure kit devices →

Sources and updates

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