Micro-Introducer KitRecalls & reported problems across all models

We found 5 models of Micro-Introducer Kit by Galt Medical Corp. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2017 and Jun 3, 2022 — classified as 1 injury, 3 malfunctions.

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

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Micro-Introducer Kit recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 27, 2025Open, Classified

   Due to a potential open seal in the sterile barrier packaging.

   Z-1735-2025 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

Most reported Micro-Introducer Kit problems

Micro-Introducer Kit models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Micro-Introducer Kit KIT-002-28

  Percutaneous Sheath Introducer Kit
  1 recall2 reports
• Micro-Introducer Kit KIT-002-34

  Percutaneous Sheath Introducer Kit
  1 recall0 reports
• Micro-Introducer Kit KIT-002-35

  Percutaneous Sheath Introducer Kit
  1 recall0 reports
• Micro-Introducer Kit KIT-002-27

  Percutaneous Sheath Introducer Kit
  1 report
• Micro-Introducer Kit KIT-075-01

  Percutaneous Sheath Introducer Kit
  1 report

Recent Micro-Introducer Kit adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2022Break; Physical Resistance/Sticking

  AS RECEIVED FROM DISTRIBUTOR/END USER "THE PATIENT WHO TRIED TO TAKE AN ANGIOGRAPHY WITH USING 4FR MIK EXCEPT THE NEEDLE. DR. (B)(6), I AM USED A 22G NEEDLE WHICH IS NOT FROM GALT, AND ONLY USED GUIDE WIRE AND SHEATH WHICH ARE FROM GALT. FIRSTLY HE PUNCTURED WITH 22G NEEDLE, PUT IN THE GUIDE WIRE, TOOK OUT THE NEEDLE, AND PUT IN THE SHEATH. AFTER THAT, HE TRIED TO PULL OUT THE GUIDE WIRE, BUT HE FELT IT WAS STUCK IN SOMEWHERE. HE TRIED TO PULL OUT THE GUIDE WIRE GENTLY, BUT IT EVENTUALLY BROKE OFF AND REMAINED IN THE PATIENT'S BODY. EVENTUALLY, THE PATIENT DIDN'T GET ANGIOGRAPHY AND THE GUIDE WIRE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS FINISHED."

  Patient problems: Foreign Body In Patient

  MAUDE report 14593981 ↗
• MalfunctionSep 17, 2019Break

  AS RECEIVED BY MAIL UNDER FDA MEDWATCH REPORT NO. (MW5089045), PATIENT PRESENTED FOR THROMBOSIS OF ARTERIOVENOUS GRAFT. MICROPUNCTURE WIRE BROKE BUT WAS RETRIEVED IN ITS ENTIRETY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9079647 ↗
• 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 ↗
• 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 Galt Medical Corp. products

• Tearaway Introducer Set6 models · 1 reports · 2 recalls
• Transitionless Micro-Introducer Kit3 models · 5 reports · 1 recall
• Transitionless Stiffen Micro-Introducer Kit3 models · 3 reports · 1 recall
• Stiffen Micro-Introducer Kit3 models · 2 reports · 1 recall
• Micro-Access Tearaway Introducer Kit3 models · 1 reports · 1 recall
• Centeze Centesis Catheter2 models · 0 reports · 1 recall