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Medline Industries, Inc. VASC1165Recalls & reported problems

Medline Industries, Inc. · LEFT HEART KIT - HILL · 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 10889942955886), received between Nov 2, 2020 and Nov 2, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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

  • Gas/Air Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 2, 2020Gas/Air Leak

    IT HAS BEEN REPORTED, "THE MANIFOLD (PART OF LEFT HEART KIT) LEAKS. "AIR BUBBLES WERE INJECTED INTO A PATIENT'S CORONARY ARTERY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10770308 ↗

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Sources and updates

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