Transitionless Micro-Introducer Kit KIT-038-04Recalls & reported problems
Galt Medical Corp. · Transitionless Micro-Introducer Kit · Class 2
All models of Transitionless 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841268104556), received between Feb 25, 2021 and Feb 25, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
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
- Break1
Patient problems
- Foreign Body In Patient1
- Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2021Break
AS RECEIVED FROM SALES REP. (MICRO PUNCTURE BROKE OFF IN A PATIENT. COME TO FIND OUT THE WIRE SHEARED OFF, AND A PIECE OF THE WIRE GOT STUCK IN THE PATIENT). THE PATIENT IS OKAY. THE PIECE OF WIRE THAT SHEARED OFF DID OCCLUDE THE CIRCUMFLEX ARTERY. DOCTOR (B)(6) SAID THE PATIENT SHOULD BE FINE.
Patient problems: Foreign Body In Patient; Occlusion
MAUDE report 11380634 ↗
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
- Micro-Introducer Kit KIT-002-28Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall2 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page