Tack Endovascular System (4F, 1.5-4.9mm) 154090041Recalls & reported problems
Intact Vascular, Inc. · 90cm Catheter Length · Class 3 · Implant
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
- Jan 10, 2025Class IOpen, Classified
Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
Z-1070-2025 · Root cause: Device Design · Recall details · FDA record ↗
Other Scaffold, Dissection Repair devices
- Tack Endovascular System (6F, 3.5-6.0mm) 156120061Intact Vascular, Inc. · Scaffold, Dissection Repair1 recall2 reports
- Tack Endovascular System (6F, 4.0-8.0mm) 206120061Intact Vascular, Inc. · Scaffold, Dissection Repair1 recall0 reports
- Tack Endovascular System (4F, 1.5-4.5mm) 154150041Intact Vascular, Inc. · Scaffold, Dissection Repair7 reports
- Tack Endovascular System (6F, 4.0-8.0mm) 206135061Intact Vascular, Inc. · Scaffold, Dissection Repair7 reports
- Tack Endovascular System (6F, 3.5-6.0mm) 156135061Intact Vascular, Inc. · Scaffold, Dissection Repair3 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.
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