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Micro-Introducer Kit KIT-002-27Recalls & reported problems

Galt Medical Corp. · Micro-Introducer Kit · Class 2

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 00841268104723), received between Mar 4, 2019 and Mar 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Physical Resistance/Sticking1
  • Unraveled Material1

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.

  • MalfunctionMar 4, 2019Unraveled Material; Physical Resistance/Sticking

    AS RECEIVED FROM END USER BY MANUFACTURER (I HAD GOTTEN INTO A VESSEL WITH THE MICROPUNCTURE NEEDLE AND HAD INSERTED THE WIRE THEREAFTER. THE WIRE WAS NOT GOING IN SMOOTHLY (WHICH HAPPENS NOT INFREQUENTLY), SO I PULLED THE WIRE BACK WHILE KEEPING THE NEEDLE IN THE SAME PLACE. THE TIP OF THE WIRE WAS STUCK AND ELONGATED/UNRAVELED AS I PULLED BACK. SUBSEQUENTLY, I PULLED EVERYTHING OUT (INCLUDING THE NEEDLE) FROM THE PT'S NECK.)

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8388419 ↗

Other Percutaneous Sheath Introducer Kit devices

All Percutaneous Sheath Introducer Kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.