Micro-Introducer Kit KIT-002-28Recalls & reported problems
Galt Medical Corp. · Micro-Introducer Kit · Class 2
All models of Micro-Introducer Kit (5)
Data updated Oct 16, 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 00841268104730), received between Sep 17, 2019 and Jun 3, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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 16, 2026.
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
- Break2
- Physical Resistance/Sticking1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, 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 ↗
Other Percutaneous Sheath Introducer Kit devices
- Transcarotid/Peripheral Access Kit KIT-075-03Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall12 reports
- Transitionless Stiffen Micro-Introducer Kit KIT-039-03Galt 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
- Posi-Stick® Introducer Kit KIT-081-02Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
- Stiffen Micro-Introducer Kit KIT-011-40Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
- 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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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