Micro-Introducer Kit KIT-002-35Recalls & reported problems
Galt Medical Corp. · Micro-Introducer Kit · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 27, 2025Open, Classified
Due to a potential open seal in the sterile barrier packaging.
Z-1735-2025 · Root cause: Process control · FDA record ↗
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
- Transitionless Micro-Introducer Kit KIT-038-04Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall1 report
- Posi-Stick® Introducer Kit KIT-081-02Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
- Micro-Introducer Kit KIT-002-34Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
- Pediatric Tearaway Introducer Kit KIT-051-01Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.