Micro-Access Tearaway Introducer Kit KIT-010-12Recalls & reported problems
Galt Medical Corp. · Micro-Access Tearaway Introducer Kit · Class 2
All models of Micro-Access Tearaway 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
- 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- May 8, 2023Class IIOpen, Classified
Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
Z-1968-2023 · Root cause: Process design · Recall details · 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
- 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
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
- 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