Transitionless Stiffen Micro-Introducer KitRecalls & reported problems across all models
Galt Medical Corp. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Transitionless Stiffen Micro-Introducer Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 3 models of Transitionless Stiffen Micro-Introducer Kit by Galt Medical Corp. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between May 2, 2019 and Feb 17, 2026 — classified as 2 injuries, 1 malfunction.
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
Reports received per month, all models
Transitionless 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.
- 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 Transitionless Stiffen Micro-Introducer Kit problems
Device problems
- Break1
- Fracture1
- Material Integrity Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- Perforation of Vessels1
- Unspecified Tissue Injury1
Transitionless Stiffen Micro-Introducer Kit models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Transitionless Stiffen Micro-Introducer Kit KIT-039-03Percutaneous Sheath Introducer Kit1 recall2 reports
- Transitionless Stiffen Micro-Introducer Kit KIT-039-13Percutaneous Sheath Introducer Kit1 recall0 reports
- Transitionless Stiffen Micro-Introducer Kit KIT-039-19Percutaneous Sheath Introducer Kit1 report
Recent Transitionless Stiffen Micro-Introducer Kit adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Material Integrity Problem
ANGIOPLASTY PROCEDURE. MICROPUNCTURE SET USED FOR ANGIOGRAPHY. DURING WITHDRAWAL OF THE 4F CATHETER, IT BROKE INTO TWO PIECES. THE DISTAL PORTION REMAINED IN THE PATIENT'S RIGHT FEMORAL ARTERY, MEASURING APPROXIMATELY 10CM IN LENGTH. THIS WAS ABLE TO BE REMOVED USING A COMPLEX ENDOVASCULAR TECHNIQUE VIA CONTRALATERAL (LEFT) FEMORAL ARTERY ACCESS.
Patient problems: Perforation of Vessels
MAUDE report 24368210 ↗InjuryFeb 24, 2023Break; Break
MANUFACTURER RECEIVED VOLUNTEER MEDWATCH REPORT ON 2/22/2023 VIA EMAIL FROM FDA REGARDING BROKEN PIECE OF MICRO PUNCTURE INSIDE PATIENT BODY REPORTED BY END USER ON 2/8/2023. EVENT PROBLEM OR DESCRIPTION OF THE EVENT STATING (THE PATIENT HAD CORONARY INTERVENTION WITH PROCEDURAL SEDATION FOR CHRONIC TOTAL OCCLUSION OF RIGHT CORONARY ARTERY WITH BILATERAL FEMORAL ARTERY ACCESS. ON RIGHT FEMORAL ARTERY (RFA) ACCESS WITH MICRO PUNCTURE, GALT MICRO PUNCTURE SHEATH BROKE OFF AT HUB INSIDE RFA).
Patient problems: Unspecified Tissue Injury
MAUDE report 16438633 ↗InjuryMay 2, 2019Fracture
AS RECEIVED FROM END USER TO MANUFACTURER: THE PATIENT REQUIRED A CHEST PORT FOR CHEMOTHERAPY. WHEN PLACING PORT UNDER FLUOROSCOPY, THE RIGHT INTERNAL JUGULAR WAS IDENTIFIED. THE WIRE WAS PLACED AND THE CATHETER WAS ADVANCED OVER THE WIRE, THE CATHETER WAS THEN REMOVED AND A PEEL AWAY SHEATH PLACED DURING A REPEAT ACCESS IT WAS NOTED THE FLOPPY END OF THE WIRE HAD BEEN FRACTURED. USING ULTRASOUND AND A GOOSENECK SNARE DEVICE, THE FLOPPY END OF THE WIRE WAS REMOVED IN ITS ENTIRETY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8575389 ↗
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
- 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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