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Medline Industries, Inc. DYNJ0337465CRecalls & reported problems

Medline Industries, Inc. · PACEMAKER PACK-LF · Class 2

Data updated Oct 18, 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 10889942165346), received between Oct 13, 2017 and Oct 13, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Fire” (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

  • Fire1

Patient problems

  • Burn(s)1

Recent adverse event reports

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

  • InjuryOct 13, 2017Fire

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THERE WAS A FLASH FIRE THAT BURNED A PATIENT'S NECK.

    Patient problems: Burn(s)

    MAUDE report 6947905 ↗

Other Cardiovascular procedure kit devices

All Cardiovascular procedure kit devices →

Sources and updates

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