Stiffen Micro-Introducer Kit KIT-011-62Recalls & reported problems
Galt Medical Corp. · Stiffen Micro-Introducer Kit · Class 2
All models of 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841268105614), received between Apr 3, 2025 and Apr 3, 2025 — classified as 1 malfunction.
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.
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
- Break1
Patient problems
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
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
- Transitionless Micro-Introducer Kit KIT-038-04Galt 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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