Skip to content

Micro-Introducer Kit KIT-075-01Recalls & 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 00841268106932), received between Dec 12, 2017 and Dec 12, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

  • Device Operates Differently Than Expected1

Patient problems

  • Vascular Dissection1

Recent adverse event reports

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

  • MalfunctionDec 12, 2017Device Operates Differently Than Expected

    DISSECTION WAS NOTICED FOLLOWING POST-DILATION OF STENT AT PROXIMAL EDGE AND EXTENDING POSTERIOR TO STENT. A 8X50 VIABAHN STENT WAS PLACED TO COVER THE DISSECTION. DISSECTION WAS THOUGHT TO HAVE OCCURRED AT THE .014 WIRE CROSSING BUT AFTER REVIEW IT COULD HAVE OCCURRED AT TIME OF THE GALT MICROPUNCTURE KIT (MPK), BUT IT IS THOUGHT NOT TO HAVE BASED ON CCA LENGTH, SO THEREFORE IT IS UNKNOWN IF THE DISSECTION WAS CAUSED BY THE MPK OR THE .014 WIRE.

    Patient problems: Vascular Dissection

    MAUDE report 7108387 ↗

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.