Stiffen Micro-Introducer KitRecalls & reported problems across all models

We found 3 models of Stiffen Micro-Introducer Kit by Galt Medical Corp. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2025 and Apr 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

Stiffen 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 2 of these models · Recall details · FDA record ↗

Most reported Stiffen Micro-Introducer Kit problems

Stiffen Micro-Introducer Kit models

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

• Stiffen Micro-Introducer Kit KIT-011-62

  Percutaneous Sheath Introducer Kit
  1 recall1 report
• Stiffen Micro-Introducer Kit KIT-011-40

  Percutaneous Sheath Introducer Kit
  1 recall0 reports
• Stiffen Micro-Introducer Kit KIT-011-42

  Percutaneous Sheath Introducer Kit
  1 report

Recent Stiffen Micro-Introducer Kit adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Break; Break

  DURING REMOVAL OF THE MICRO-PUNCTURE CATHETER, THE PROXIMAL END OF THE CATHETER REMAINED LODGED WITHIN THE AV [ARTERIOVENOUS] GRAFT. AN OPEN CUT DOWN WAS PERFORMED TO REMOVE THE CATHETER USING A GOOSENECK SNARE. A VENOGRAM WAS COMPLETED TO ENSURE NO RESIDUAL MATERIAL WITHIN THE AV GRAFT AND/OR VENOUS SYSTEM ALTHOUGH A SIGNIFICANT DEFECT WAS NOTED IN THE AV GRAFT THAT WAS REPAIRED WITH COVERA COVERED STENT GRAFT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21769518 ↗
• MalfunctionMar 28, 2025Material Integrity Problem; Material Integrity Problem

  DURING THE PROCEDURE, THE 4FR MICROPUNCTURE CATHETER WAS THEN REMOVED FROM THE WIRE AND FOUND TO BE FRACTURED AND RETAINED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 21719286 ↗

Other Galt Medical Corp. products

• Tearaway Introducer Set6 models · 1 reports · 2 recalls
• Transitionless Micro-Introducer Kit3 models · 5 reports · 1 recall
• Micro-Introducer Kit5 models · 4 reports · 1 recall
• Transitionless Stiffen Micro-Introducer Kit3 models · 3 reports · 1 recall
• Micro-Access Tearaway Introducer Kit3 models · 1 reports · 1 recall
• Centeze Centesis Catheter2 models · 0 reports · 1 recall