Tearaway Introducer SetRecalls & reported problems across all models
Galt Medical Corp. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Tearaway Introducer Set model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 6 models of Tearaway Introducer Set by Galt Medical Corp. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Mar 6, 2024 and Mar 6, 2024 — classified as 1 malfunction.
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Tearaway Introducer Set recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 27, 2025Open, Classified
Due to a potential open seal in the sterile barrier packaging.
Z-1737-2025 · Root cause: Process control · Recall details · FDA record ↗
- May 8, 2023Open, 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-1969-2023 · Root cause: Process design · names 4 of these models · Recall details · FDA record ↗
Most reported Tearaway Introducer Set problems
Patient problems
- Needle Stick/Puncture1
Tearaway Introducer Set models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tearaway Introducer Set INT-105-25Introducer, Catheter1 recall0 reports
- Tearaway Introducer Set INT-106-09Introducer, Catheter1 recall0 reports
- Tearaway Introducer Set INT-106-12Introducer, Catheter1 recall0 reports
- Tearaway Introducer Set INT-106-17Introducer, Catheter1 recall0 reports
- Tearaway Introducer Set INT-101-15Introducer, Catheter1 recall0 reports
- Tearaway Introducer Set INT-106-04Introducer, Catheter1 report
Recent Tearaway Introducer Set adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2024
WHILE PLACING 5 F PICC THE CATHETER WAS UNABLE TO THREAD THROUGH THE 5 FRENCH GALT TEARAWAY INTRODUCER. ULTIMATELY, PATIENT REQUIRED A SECOND NEEDLE INSERTION AFTER THIS INTRODUCER WAS REMOVED.
Patient problems: Needle Stick/Puncture
MAUDE report 18845733 ↗
Other Galt Medical Corp. products
- Transitionless Micro-Introducer Kit3 models · 5 reports · 1 recall
- Micro-Introducer Kit5 models · 4 reports · 1 recall
- Transitionless Stiffen Micro-Introducer Kit3 models · 3 reports · 1 recall
- Stiffen Micro-Introducer Kit3 models · 2 reports · 1 recall
- Micro-Access Tearaway Introducer Kit3 models · 1 reports · 1 recall
- Centeze Centesis Catheter2 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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