Transitionless Stiffen Micro-Introducer Kit KIT-039-03Recalls & reported problems
Galt Medical Corp. · Transitionless Stiffen Micro-Introducer Kit · Class 2
All models of Transitionless Stiffen Micro-Introducer Kit (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841268104587), received between May 2, 2019 and Feb 17, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Mar 27, 2025Class IIOpen, Classified
Due to a potential open seal in the sterile barrier packaging.
Z-1735-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture1
- Material Integrity Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- Perforation of Vessels1
Recent adverse event reports
The 2 most recent of 2 reports, 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 ↗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 Percutaneous Sheath Introducer Kit devices
- Transcarotid/Peripheral Access Kit KIT-075-03Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall12 reports
- Micro-Introducer Kit KIT-002-28Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall2 reports
- Transitionless Micro-Introducer Kit KIT-038-04Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall1 report
- Stiffen Micro-Introducer Kit KIT-011-62Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall1 report
- Micro-Introducer Kit KIT-002-35Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
- Pediatric Tearaway Introducer Kit KIT-051-01Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
- Transitionless Stiffen Micro-Introducer Kit KIT-039-13Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
- Micro-Access Tearaway Introducer Kit KIT-010-12Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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